<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03020407</url>
  </required_header>
  <id_info>
    <org_study_id>589/59</org_study_id>
    <nct_id>NCT03020407</nct_id>
  </id_info>
  <brief_title>The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation</brief_title>
  <official_title>The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock&#xD;
      patients who are treated with ultrasound-assisted fluid management using change of the&#xD;
      inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared&#xD;
      with those treated with &quot;usual-care&quot; strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Septic shock (SS) is globally prevalent in with high mortality rate.The current focuses on&#xD;
      initial treatment of this condition emphasize on the early recognition, prompt administration&#xD;
      of antibiotic, and restoration of hemodynamic with aggressive fluid resuscitation and&#xD;
      vasopressor. Regarding the initial fluid therapy, administration of empirical crystalloid at&#xD;
      the dose of 30 ml/kg is recommended in the guideline. The ultrasound-assisted management of&#xD;
      shock patients has been introduced in the past decade and now is widely used. By using the&#xD;
      measurement of inferior vena cava (IVC) diameter change during respiratory phases, physicians&#xD;
      can predict the fluid responsiveness in the shock patients and tailor the fluid therapy&#xD;
      during the resuscitation.Unfortunately, clinical outcome related to the use of this concept&#xD;
      in SS resuscitation has not been well studied. Inadequate resuscitation with fluid therapy is&#xD;
      related with higher mortality; however, fluid bolus or positive fluid balance that may result&#xD;
      from &quot;too aggressive&quot; fluid administration is also associated with increased mortality in SS&#xD;
      patients. The primary aim of this study was to evaluate the 30-day mortality outcome of the&#xD;
      SS patients who were treated with ultrasound-assisted fluid management using change of the&#xD;
      IVC during respiratory phases in the first 6 hours compared with those who were treated with&#xD;
      &quot;usual-care&quot; strategy. The secondary outcomes were to compare the rate of the need for&#xD;
      mechanical ventilation (MV) and renal replacement therapy (RRT) as well as the 6-hours&#xD;
      lactate clearance and the change in Sequential Organ Failure (SOFA) score in 72 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day Mortality</measure>
    <time_frame>30 day after randomization</time_frame>
    <description>30-day mortality related to septic shock</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage Change of 6-hour Lactate</measure>
    <time_frame>6 hours after treatment</time_frame>
    <description>The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-hour Cumulative Amount of Intravenous Fluid (mL)</measure>
    <time_frame>6 hours after treatment</time_frame>
    <description>Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment</measure>
    <time_frame>72 hours after treatment</time_frame>
    <description>Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment</measure>
    <time_frame>72 hours after treatment</time_frame>
    <description>The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>IVC Ultrasound-guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IVC Ultrasound-guided</intervention_name>
    <description>IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.</description>
    <arm_group_label>IVC Ultrasound-guided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antibiotics</intervention_name>
    <description>Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
    <arm_group_label>IVC Ultrasound-guided</arm_group_label>
    <other_name>Antimicrobials</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressor</intervention_name>
    <description>The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
    <arm_group_label>IVC Ultrasound-guided</arm_group_label>
    <other_name>Norepinephrine, dopamine, epinephrine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who attended the emergency department with septic shock (defined by those who&#xD;
             require a vasopressor to maintain a mean arterial pressure (MAP) of 65 mm Hg or&#xD;
             greater and whose serum lactate level greater than 2 mmol/L in the absence of&#xD;
             hypovolemia.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Congestive pulmonary edema or known to have poor systolic cardiac function (left&#xD;
             ventricular ejection fraction ≤ 40%).&#xD;
&#xD;
          -  2) Known to have right heart pathologies.&#xD;
&#xD;
          -  3) Having or suspected to have marked ascites, significant bowel dilatation or the&#xD;
             conditions that can cause abdominal hypertension.&#xD;
&#xD;
          -  4) Body mass index ≥ 30 kg/square meter.&#xD;
&#xD;
          -  5) Having concomitant attack of severe airway disease (eg. Asthma, COPD) that may have&#xD;
             confounded the IVC interpretation due to the positive intrathoracic pressure.&#xD;
&#xD;
          -  6) IVC can not be identified or its diameter cannot be measured correctly.&#xD;
&#xD;
          -  7) Having end-stage renal diseases with or without dialysis.&#xD;
&#xD;
          -  8) Having non-infectious diseases as final diagnoses.&#xD;
&#xD;
          -  9) Pregnant women.&#xD;
&#xD;
          -  10) Have been referred or treated from other healthcare facility.&#xD;
&#xD;
          -  11) Having active hemorrhages.&#xD;
&#xD;
          -  12) Duplicated cases.&#xD;
&#xD;
          -  13) who had &quot;do-not-resuscitate&quot; living will.&#xD;
&#xD;
          -  14) Declined to consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khrongwong Musikatavorn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Medicine Unit, King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Pathum Wan</city>
        <state>Bangkok</state>
        <zip>11130</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.</citation>
    <PMID>33856325</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>May 4, 2021</results_first_submitted>
  <results_first_submitted_qc>August 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2021</results_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Septic Shock</keyword>
  <keyword>Inferior vene cava diameter</keyword>
  <keyword>Resuscitation</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
    <mesh_term>Vasoconstrictor Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03020407/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IVC Ultrasound-guided</title>
          <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IVC Ultrasound-guided</title>
          <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.3" spread="20.1"/>
                    <measurement group_id="B2" value="63.7" spread="16.8"/>
                    <measurement group_id="B3" value="64.5" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patients with infections</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>30-day Mortality</title>
        <description>30-day mortality related to septic shock</description>
        <time_frame>30 day after randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVC Ultrasound-guided</title>
            <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
          </group>
        </group_list>
        <measure>
          <title>30-day Mortality</title>
          <description>30-day mortality related to septic shock</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change of 6-hour Lactate</title>
        <description>The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome.</description>
        <time_frame>6 hours after treatment</time_frame>
        <population>Data of 6-hour lactate was obtained among 100 patients (missing data in one patient) in the Usual care group and 100 patients (missing data in one patient) in the IVC Ultrasound-guided group .</population>
        <group_list>
          <group group_id="O1">
            <title>IVC Ultrasound-guided</title>
            <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change of 6-hour Lactate</title>
          <description>The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome.</description>
          <population>Data of 6-hour lactate was obtained among 100 patients (missing data in one patient) in the Usual care group and 100 patients (missing data in one patient) in the IVC Ultrasound-guided group .</population>
          <units>percentage change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2" lower_limit="7.4" upper_limit="60"/>
                    <measurement group_id="O2" value="35.9" lower_limit="16.3" upper_limit="65.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6-hour Cumulative Amount of Intravenous Fluid (mL)</title>
        <description>Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment.</description>
        <time_frame>6 hours after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVC Ultrasound-guided</title>
            <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
          </group>
        </group_list>
        <measure>
          <title>6-hour Cumulative Amount of Intravenous Fluid (mL)</title>
          <description>Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment.</description>
          <units>mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1900" lower_limit="1500" upper_limit="2570"/>
                    <measurement group_id="O2" value="2600" lower_limit="2300" upper_limit="3220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment</title>
        <description>Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment.</description>
        <time_frame>72 hours after treatment</time_frame>
        <population>Data of 72-hour cumulative amount of intravenous fluid was available among 83 patients (missing data in 18 patients; 6 discharge within 72 hours, 5 transfer out, 4 missing records and 3 death within 72 hours) in the Usual care group and 79 patients (missing data in 22 patients, 10 discharge within 72 hours, 4 transfer out, 3 missing records, 5 death within 72 hours) in the IVC Ultrasound-guided group .</population>
        <group_list>
          <group group_id="O1">
            <title>IVC Ultrasound-guided</title>
            <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
          </group>
        </group_list>
        <measure>
          <title>72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment</title>
          <description>Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment.</description>
          <population>Data of 72-hour cumulative amount of intravenous fluid was available among 83 patients (missing data in 18 patients; 6 discharge within 72 hours, 5 transfer out, 4 missing records and 3 death within 72 hours) in the Usual care group and 79 patients (missing data in 22 patients, 10 discharge within 72 hours, 4 transfer out, 3 missing records, 5 death within 72 hours) in the IVC Ultrasound-guided group .</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7,300" lower_limit="5040" upper_limit="9200"/>
                    <measurement group_id="O2" value="7,702" lower_limit="5900" upper_limit="11275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment</title>
        <description>The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome.</description>
        <time_frame>72 hours after treatment</time_frame>
        <population>Data of 72-hour cumulative amount of intravenous fluid was available among 86 patients (missing data in 15 patients; 6 discharge within 72 hours, 5 transfer out, 1 lack of sufficient information and 3 death within 72 hours) in the Usual care group and 78 patients (missing data in 23 patients, 10 discharge within 72 hours, 4 transfer out, 4 lack of sufficient information, 5 death within 72 hours ) in the IVC Ultrasound-guided group .</population>
        <group_list>
          <group group_id="O1">
            <title>IVC Ultrasound-guided</title>
            <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment</title>
          <description>The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome.</description>
          <population>Data of 72-hour cumulative amount of intravenous fluid was available among 86 patients (missing data in 15 patients; 6 discharge within 72 hours, 5 transfer out, 1 lack of sufficient information and 3 death within 72 hours) in the Usual care group and 78 patients (missing data in 23 patients, 10 discharge within 72 hours, 4 transfer out, 4 lack of sufficient information, 5 death within 72 hours ) in the IVC Ultrasound-guided group .</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="-1" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="-1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IVC Ultrasound-guided</title>
          <description>The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI &gt; 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI &gt; 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI &lt; 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.&#xD;
Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.&#xD;
Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal replacement therapy</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Mechanical ventilator</sub_title>
                <counts group_id="E1" events="23" subjects_affected="23" subjects_at_risk="101"/>
                <counts group_id="E2" events="30" subjects_affected="30" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="101" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E2" events="101" subjects_affected="2" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was conducted with the specific study protocol at a single, tertiary-care hospital. Second, physicians should use cautious clinical judgment or different approaches in different types of patients. The interpersonal variation and sampling position may have affected the consistency of IVC diameter measurement.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Khrongwong Musikatavorn</name_or_title>
      <organization>Department of Emergency Medicine, Faculty of Medicine, Chulalongkorn University</organization>
      <phone>+6626494000 ext 83058</phone>
      <email>kmusikatavorn@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03020407
org study id: 589/59
nct id: NCT03020407
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock
      patients who are treated with ultrasound-assisted fluid management using change of the
      inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared
      with those treated with "usual-care" strategy.
Septic shock (SS) is globally prevalent in with high mortality rate.The current focuses on
      initial treatment of this condition emphasize on the early recognition, prompt administration
      of antibiotic, and restoration of hemodynamic with aggressive fluid resuscitation and
      vasopressor. Regarding the initial fluid therapy, administration of empirical crystalloid at
      the dose of 30 ml/kg is recommended in the guideline. The ultrasound-assisted management of
      shock patients has been introduced in the past decade and now is widely used. By using the
      measurement of inferior vena cava (IVC) diameter change during respiratory phases, physicians
      can predict the fluid responsiveness in the shock patients and tailor the fluid therapy
      during the resuscitation.Unfortunately, clinical outcome related to the use of this concept
      in SS resuscitation has not been well studied. Inadequate resuscitation with fluid therapy is
      related with higher mortality; however, fluid bolus or positive fluid balance that may result
      from "too aggressive" fluid administration is also associated with increased mortality in SS
      patients. The primary aim of this study was to evaluate the 30-day mortality outcome of the
      SS patients who were treated with ultrasound-assisted fluid management using change of the
      IVC during respiratory phases in the first 6 hours compared with those who were treated with
      "usual-care" strategy. The secondary outcomes were to compare the rate of the need for
      mechanical ventilation (MV) and renal replacement therapy (RRT) as well as the 6-hours
      lactate clearance and the change in Sequential Organ Failure (SOFA) score in 72 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 30-day Mortality
time frame: 30 day after randomization
description: 30-day mortality related to septic shock
measure: Percentage Change of 6-hour Lactate
time frame: 6 hours after treatment
description: The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome.
measure: 6-hour Cumulative Amount of Intravenous Fluid (mL)
time frame: 6 hours after treatment
description: Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment.
measure: 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment
time frame: 72 hours after treatment
description: Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment.
measure: Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment
time frame: 72 hours after treatment
description: The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome.
arm group label: IVC Ultrasound-guided
arm group type: Experimental
description: The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
arm group label: Usual care
arm group type: No Intervention
description: Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
intervention type: Procedure
intervention name: IVC Ultrasound-guided
description: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.
arm group label: IVC Ultrasound-guided
intervention type: Drug
intervention name: Antibiotics
description: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
arm group label: IVC Ultrasound-guided
other name: Antimicrobials
intervention type: Drug
intervention name: Vasopressor
description: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.
arm group label: IVC Ultrasound-guided
other name: Norepinephrine, dopamine, epinephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Khrongwong Musikatavorn, MD
role: Principal Investigator
affiliation: Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital
facility: 
country: Thailand
citation: Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
PMID: 33856325
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Shock
mesh term: Anti-Bacterial Agents
mesh term: Dopamine
mesh term: Epinephrine
mesh term: Norepinephrine
mesh term: Vasoconstrictor Agents
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was conducted with the specific study protocol at a single, tertiary-care hospital. Second, physicians should use cautious clinical judgment or different approaches in different types of patients. The interpersonal variation and sampling position may have affected the consistency of IVC diameter measurement.
point of contact: 