<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/NCT03296319</url>
  </required_header>
  <id_info>
    <org_study_id>Echocardiography guided fluid</org_study_id>
    <nct_id>NCT03296319</nct_id>
  </id_info>
  <brief_title>Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.</brief_title>
  <official_title>Echocardiography Guided Fluid Resuscitation in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare between the impact of echocardiography guided fluid resuscitation and clinically&#xD;
      guided fluid resuscitation on critically ill patients in hospital outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resuscitation often requires the infusion of intravenous fluid in an effort to reverse organ&#xD;
      dysfunction. The harms of inappropriate use of fluid are becoming increasingly apparent The&#xD;
      question of whether the patient improves with fluid, additional vasopressors or inotropes can&#xD;
      be difficult to answer. The gold standard for assessing fluid responsiveness to guide fluid&#xD;
      administration in critically ill patients is to perform a fluid challenge. The rationale for&#xD;
      volume expansion is to increase the cardiac output (CO) and oxygen delivery to ultimately&#xD;
      improve tissue oxygenation. This involves the infusion of a specific amount of intravenous&#xD;
      fluid to assess ventricular preload reserve and subsequent systemic haemodynamic effects. In&#xD;
      a patient with acute hemodynamic instability, a fluid challenge will cause an increase in&#xD;
      stroke volume, according to the Frank-Starling curve. This increase in stroke volume has a&#xD;
      salutary effect because it improves tissue perfusion. In contrast, higher hydrostatic&#xD;
      pressures in the vascular system predispose the patient to edema, organic dysfunction, and&#xD;
      increased risk of in-hospital mortality.&#xD;
&#xD;
      Fluid responsiveness is conventionally defined as an increase of at least 10% to 15% in SV in&#xD;
      response to a fluid challenge, which is a reflection of the limits of precision of the&#xD;
      technology used.&#xD;
&#xD;
      Assessment of the response in flow to a fluid challenge can be guided with echocardiography.&#xD;
      It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VTI)&#xD;
      immediately before and after fluid challenge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The impact of echocardiography guided fluid resuscitation</measure>
    <time_frame>Baseline</time_frame>
    <description>we will compare the results of fluid administration between two groups of patients with APACHE II score &gt; 25: the first group using clinical sense only and the other group using transthoracic echocardiography including: The sample box of PW Doppler will be placed at thelevel of the aortic valve or within 1 cm of it, in the LVOT. Peak velocity variation of 12% before and after 250 cc normal saline challenge in adults predicts fluid responsiveness (12) and VTI variation is also predictive. The percentage variations in SV, VTI or peak velocity are calculated using the following equation: variations =100 x svmax-svmin/(svmax+svmin) x 0.5.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Fluid Responsiveness</condition>
  <condition>Echocardiography</condition>
  <arm_group>
    <arm_group_label>echocardiography guided fluid resuscitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>clinically guided fluid resuscitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Echocardiography guided fluid administration</description>
    <arm_group_label>clinically guided fluid resuscitation</arm_group_label>
    <arm_group_label>echocardiography guided fluid resuscitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1- All Critical ill-patients with Acute Physiologic Assessment and Chronic Health&#xD;
        Evaluation II score (APACHE II score)≥ 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bad echocardiographic window&#xD;
&#xD;
          2. APACHE II score &lt; 25.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>faculty of medicine, Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Jonas MM, Tanser SJ. Lithium dilution measurement of cardiac output and arterial pulse waveform analysis: an indicator dilution calibrated beat-by-beat system for continuous estimation of cardiac output. Curr Opin Crit Care. 2002 Jun;8(3):257-61. doi: 10.1097/00075198-200206000-00010.</citation>
    <PMID>12386506</PMID>
  </results_reference>
  <results_reference>
    <citation>National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.</citation>
    <PMID>16714767</PMID>
  </results_reference>
  <results_reference>
    <citation>Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.</citation>
    <PMID>20975548</PMID>
  </results_reference>
  <results_reference>
    <citation>Squara P, Cecconi M, Rhodes A, Singer M, Chiche JD. Tracking changes in cardiac output: methodological considerations for the validation of monitoring devices. Intensive Care Med. 2009 Oct;35(10):1801-8. doi: 10.1007/s00134-009-1570-9. Epub 2009 Jul 11.</citation>
    <PMID>19593546</PMID>
  </results_reference>
  <results_reference>
    <citation>Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011 Jun;17(3):290-5. doi: 10.1097/MCC.0b013e32834699cd.</citation>
    <PMID>21508838</PMID>
  </results_reference>
  <results_reference>
    <citation>Hofer CK, Cannesson M. Monitoring fluid responsiveness. Acta Anaesthesiol Taiwan. 2011 Jun;49(2):59-65. doi: 10.1016/j.aat.2011.05.001. Epub 2011 Jun 24.</citation>
    <PMID>21729812</PMID>
  </results_reference>
  <results_reference>
    <citation>Vincent JL. &quot;Let's give some fluid and see what happens&quot; versus the &quot;mini-fluid challenge&quot;. Anesthesiology. 2011 Sep;115(3):455-6. doi: 10.1097/ALN.0b013e318229a521. No abstract available.</citation>
    <PMID>21792055</PMID>
  </results_reference>
  <results_reference>
    <citation>Frazee E, Kashani K. Fluid Management for Critically Ill Patients: A Review of the Current State of Fluid Therapy in the Intensive Care Unit. Kidney Dis (Basel). 2016 Jun;2(2):64-71. doi: 10.1159/000446265. Epub 2016 May 18.</citation>
    <PMID>27536694</PMID>
  </results_reference>
  <results_reference>
    <citation>Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.</citation>
    <PMID>12065368</PMID>
  </results_reference>
  <results_reference>
    <citation>Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.</citation>
    <PMID>3928249</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen C, Kollef MH. Conservative fluid therapy in septic shock: an example of targeted therapeutic minimization. Crit Care. 2014 Aug 29;18(4):481. doi: 10.1186/s13054-014-0481-5.</citation>
    <PMID>25185073</PMID>
  </results_reference>
  <results_reference>
    <citation>Teboul JL, Monnet X. Prediction of volume responsiveness in critically ill patients with spontaneous breathing activity. Curr Opin Crit Care. 2008 Jun;14(3):334-9. doi: 10.1097/MCC.0b013e3282fd6e1e.</citation>
    <PMID>18467896</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Esam</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03296319
org study id: Echocardiography guided fluid
nct id: NCT03296319
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare between the impact of echocardiography guided fluid resuscitation and clinically
      guided fluid resuscitation on critically ill patients in hospital outcome.
Resuscitation often requires the infusion of intravenous fluid in an effort to reverse organ
      dysfunction. The harms of inappropriate use of fluid are becoming increasingly apparent The
      question of whether the patient improves with fluid, additional vasopressors or inotropes can
      be difficult to answer. The gold standard for assessing fluid responsiveness to guide fluid
      administration in critically ill patients is to perform a fluid challenge. The rationale for
      volume expansion is to increase the cardiac output (CO) and oxygen delivery to ultimately
      improve tissue oxygenation. This involves the infusion of a specific amount of intravenous
      fluid to assess ventricular preload reserve and subsequent systemic haemodynamic effects. In
      a patient with acute hemodynamic instability, a fluid challenge will cause an increase in
      stroke volume, according to the Frank-Starling curve. This increase in stroke volume has a
      salutary effect because it improves tissue perfusion. In contrast, higher hydrostatic
      pressures in the vascular system predispose the patient to edema, organic dysfunction, and
      increased risk of in-hospital mortality.

      Fluid responsiveness is conventionally defined as an increase of at least 10% to 15% in SV in
      response to a fluid challenge, which is a reflection of the limits of precision of the
      technology used.

      Assessment of the response in flow to a fluid challenge can be guided with echocardiography.
      It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VTI)
      immediately before and after fluid challenge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The impact of echocardiography guided fluid resuscitation
time frame: Baseline
description: we will compare the results of fluid administration between two groups of patients with APACHE II score > 25: the first group using clinical sense only and the other group using transthoracic echocardiography including: The sample box of PW Doppler will be placed at thelevel of the aortic valve or within 1 cm of it, in the LVOT. Peak velocity variation of 12% before and after 250 cc normal saline challenge in adults predicts fluid responsiveness (12) and VTI variation is also predictive. The percentage variations in SV, VTI or peak velocity are calculated using the following equation: variations =100 x svmax-svmin/(svmax+svmin) x 0.5.
arm group label: echocardiography guided fluid resuscitation
arm group type: Active Comparator
arm group label: clinically guided fluid resuscitation
arm group type: Experimental
intervention type: Device
intervention name: Echocardiography
description: Echocardiography guided fluid administration
arm group label: clinically guided fluid resuscitation
arm group label: echocardiography guided fluid resuscitation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
citation: Jonas MM, Tanser SJ. Lithium dilution measurement of cardiac output and arterial pulse waveform analysis: an indicator dilution calibrated beat-by-beat system for continuous estimation of cardiac output. Curr Opin Crit Care. 2002 Jun;8(3):257-61. doi: 10.1097/00075198-200206000-00010.
PMID: 12386506
citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
PMID: 16714767
citation: Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.
PMID: 20975548
citation: Squara P, Cecconi M, Rhodes A, Singer M, Chiche JD. Tracking changes in cardiac output: methodological considerations for the validation of monitoring devices. Intensive Care Med. 2009 Oct;35(10):1801-8. doi: 10.1007/s00134-009-1570-9. Epub 2009 Jul 11.
PMID: 19593546
citation: Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011 Jun;17(3):290-5. doi: 10.1097/MCC.0b013e32834699cd.
PMID: 21508838
citation: Hofer CK, Cannesson M. Monitoring fluid responsiveness. Acta Anaesthesiol Taiwan. 2011 Jun;49(2):59-65. doi: 10.1016/j.aat.2011.05.001. Epub 2011 Jun 24.
PMID: 21729812
citation: Vincent JL. "Let's give some fluid and see what happens" versus the "mini-fluid challenge". Anesthesiology. 2011 Sep;115(3):455-6. doi: 10.1097/ALN.0b013e318229a521. No abstract available.
PMID: 21792055
citation: Frazee E, Kashani K. Fluid Management for Critically Ill Patients: A Review of the Current State of Fluid Therapy in the Intensive Care Unit. Kidney Dis (Basel). 2016 Jun;2(2):64-71. doi: 10.1159/000446265. Epub 2016 May 18.
PMID: 27536694
citation: Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
PMID: 12065368
citation: Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PMID: 3928249
citation: Chen C, Kollef MH. Conservative fluid therapy in septic shock: an example of targeted therapeutic minimization. Crit Care. 2014 Aug 29;18(4):481. doi: 10.1186/s13054-014-0481-5.
PMID: 25185073
citation: Teboul JL, Monnet X. Prediction of volume responsiveness in critically ill patients with spontaneous breathing activity. Curr Opin Crit Care. 2008 Jun;14(3):334-9. doi: 10.1097/MCC.0b013e3282fd6e1e.
PMID: 18467896
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Esam
investigator title: Assistant Lecturer
mesh term: Critical Illness