<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/NCT02977429</url>
  </required_header>
  <id_info>
    <org_study_id>bc2016032</org_study_id>
    <nct_id>NCT02977429</nct_id>
  </id_info>
  <brief_title>Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery</brief_title>
  <official_title>Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy&#xD;
      and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal&#xD;
      tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect&#xD;
      of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Confirmed that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the&#xD;
           evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor&#xD;
           surgery, and is expected to be a new monitoring index to improve the therapeutic&#xD;
           efficacy of this kind of patients.&#xD;
&#xD;
        2. Pcv-aCO2 effectively reflected the improvement of tissue and organ microcirculation&#xD;
           disorder through the individual goal target treatment to guide the fluid resuscitation&#xD;
           in the hemodynamic instability patients.&#xD;
&#xD;
        3. Research of the correlation between Pcv-aCO2 and the organ function in patients with&#xD;
           abnormal hemodynamics after operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>The change of Pcv-aCO2</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The treatment success rate in different groups</measure>
    <time_frame>Twenty-eighth days after admission</time_frame>
    <description>Collect the index of treatment success rate(%) of patients in different groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 28 day mortality in different groups</measure>
    <time_frame>Twenty-eighth days after admission</time_frame>
    <description>Collect the index of 28 day mortality(%) of patients in different groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The hospitalization course in different groups</measure>
    <time_frame>Twenty-eighth days after admission</time_frame>
    <description>Collect the index of hospitalization course(days) of patients in different groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The change of Central Venous Oxygen Saturation (ScvO2)</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>The change of hemoglobin (Hb)</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>The change of blood lactic acid (Lac)</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>The change of blood lactic acid (Lac, mmol/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>The change of Cardiac Index (CI)</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>The change of Cardiac Index (CI, L/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Oxygen Supply status (DO2) in different groups</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>Collect the index of oxygen supply (DO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Oxygen Consumption (VO2) in different groups</measure>
    <time_frame>fluid resuscitation for 6 hours, 12 hours and 24 hours</time_frame>
    <description>Collect the index of oxygen consumption (VO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Abdominal Tumor</condition>
  <condition>Abdominal Infection</condition>
  <arm_group>
    <arm_group_label>standard group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.than collect the data of ScvO2 and Pcv-aCO2:&#xD;
ScvO2≥70%，and furthermore, Pcv-aCO2 is divided into &quot;≤6mmHg&quot; and &quot;&gt;6mmHg&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The patients with ScvO2 &lt;70% will receive the standardized fluid therapy for 6 hours.than collect the data of ScvO2 and Pcv-aCO2:&#xD;
ScvO2&lt;70%，and furthermore, Pcv-aCO2 is divided into &quot;≤6mmHg&quot; and &quot;&gt;6mmHg&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standardized fluid therapy</intervention_name>
    <description>The patients with ScvO2 &lt;70% will receive the standardized fluid therapy for 6 hours.</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>Therapeutic effect of fluid resuscitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional fluid therapy</intervention_name>
    <description>The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.</description>
    <arm_group_label>standard group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute physiology and chronic health score system II (APACHE II) score ≥10；&#xD;
&#xD;
          2. Hemodynamic abnormalities post-operation (a. systolic blood pressure&lt;90mmHg, or&#xD;
             descent by basic blood pressure for more than 40mmHg. b. pulse pressure &lt;20mmHg, c.&#xD;
             urine volume &lt;0.5ml/Kg/hr, d. heart rate &gt;100 / min, e.Central Venous Pressure(CVP)&#xD;
             &lt;5mmHg, f. blood lactic acid &gt;2.7mmol/L, meet any one above).&#xD;
&#xD;
          3. Age ≥ 18 years, which is expected to stay in ICU for 5 days or longer;&#xD;
&#xD;
          4. Patients themselves or their authorized clients agree to participate in clinical&#xD;
             trials and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age &lt;18 years;&#xD;
&#xD;
          2. without improvement in respiratory system disease or chronic obstructive pulmonary&#xD;
             disease with Forced expiratory volume in one second (FEV1) &lt;50%;&#xD;
&#xD;
          3. lobectomy and pneumonectomy;&#xD;
&#xD;
          4. death within 24 after treatment;&#xD;
&#xD;
          5. patients with severe organ dysfunction;&#xD;
&#xD;
          6. pregnant or lactating women;&#xD;
&#xD;
          7. the patients did not sign informed consent;&#xD;
&#xD;
          8. any factors that may be expected to increase the risk of patients or other factors&#xD;
             that may interfere with the results of clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wanhua Wang, director</last_name>
    <role>Study Director</role>
    <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Yang, physician</last_name>
    <phone>022-23340123</phone>
    <phone_ext>1021</phone_ext>
    <email>yyicu3021@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yang Lu, physician</last_name>
    <phone>022-23340123</phone>
    <phone_ext>1021</phone_ext>
    <email>Yang_lu1299@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wanhua Wang, director</last_name>
      <phone>23340123</phone>
      <phone_ext>1021</phone_ext>
      <email>Wanhua_Wang1962@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.</citation>
    <PMID>21034476</PMID>
  </reference>
  <reference>
    <citation>Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.</citation>
    <PMID>20179283</PMID>
  </reference>
  <reference>
    <citation>Pope JV, Jones AE, Gaieski DF, Arnold RC, Trzeciak S, Shapiro NI; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of central venous oxygen saturation (ScvO(2)) as a predictor of mortality in patients with sepsis. Ann Emerg Med. 2010 Jan;55(1):40-46.e1. doi: 10.1016/j.annemergmed.2009.08.014. Epub 2009 Oct 25.</citation>
    <PMID>19854541</PMID>
  </reference>
  <reference>
    <citation>Harilall Y, Adam JK, Biccard BM, Reddi A. Correlation between cerebral tissue and central venous oxygen saturation during off-pump coronary bypass graft surgery. Perfusion. 2011 Mar;26(2):83-90. doi: 10.1177/0267659110387846. Epub 2010 Nov 15.</citation>
    <PMID>21078769</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 27, 2016</last_update_submitted>
  <last_update_submitted_qc>November 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tumor</keyword>
  <keyword>Abdominal infection</keyword>
  <keyword>Hemodynamics</keyword>
  <keyword>Pcv-aCO2</keyword>
  <keyword>Early Goal-directed Therapy (EGDT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intraabdominal Infections</mesh_term>
    <mesh_term>Abdominal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02977429
org study id: bc2016032
nct id: NCT02977429
lead sponsor: 
has dmc: Yes
This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy
      and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal
      tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect
      of these patients.
1. Confirmed that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the
           evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor
           surgery, and is expected to be a new monitoring index to improve the therapeutic
           efficacy of this kind of patients.

        2. Pcv-aCO2 effectively reflected the improvement of tissue and organ microcirculation
           disorder through the individual goal target treatment to guide the fluid resuscitation
           in the hemodynamic instability patients.

        3. Research of the correlation between Pcv-aCO2 and the organ function in patients with
           abnormal hemodynamics after operation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The change of Pcv-aCO2
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
measure: The treatment success rate in different groups
time frame: Twenty-eighth days after admission
description: Collect the index of treatment success rate(%) of patients in different groups.
measure: The 28 day mortality in different groups
time frame: Twenty-eighth days after admission
description: Collect the index of 28 day mortality(%) of patients in different groups.
measure: The hospitalization course in different groups
time frame: Twenty-eighth days after admission
description: Collect the index of hospitalization course(days) of patients in different groups.
measure: The change of Central Venous Oxygen Saturation (ScvO2)
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
measure: The change of hemoglobin (Hb)
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
measure: The change of blood lactic acid (Lac)
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: The change of blood lactic acid (Lac, mmol/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
measure: The change of Cardiac Index (CI)
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: The change of Cardiac Index (CI, L/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
measure: The Oxygen Supply status (DO2) in different groups
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: Collect the index of oxygen supply (DO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
measure: The Oxygen Consumption (VO2) in different groups
time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
description: Collect the index of oxygen consumption (VO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
arm group label: standard group
arm group type: Active Comparator
description: The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.than collect the data of ScvO2 and Pcv-aCO2:
ScvO2≥70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and ">6mmHg"
arm group label: control group
arm group type: Sham Comparator
description: The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.than collect the data of ScvO2 and Pcv-aCO2:
ScvO2<70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and ">6mmHg"
intervention type: Other
intervention name: standardized fluid therapy
description: The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.
arm group label: control group
other name: Therapeutic effect of fluid resuscitation
intervention type: Other
intervention name: conventional fluid therapy
description: The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.
arm group label: standard group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wanhua Wang, director
role: Study Director
affiliation: Tianjin Medical University Cancer Institute and Hospital
last name: Yang Yang, physician
phone: 022-23340123
phone ext: 1021
email: yyicu3021@126.com
last name: Yang Lu, physician
phone: 022-23340123
phone ext: 1021
email: Yang_lu1299@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.
PMID: 21034476
citation: Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
PMID: 20179283
citation: Pope JV, Jones AE, Gaieski DF, Arnold RC, Trzeciak S, Shapiro NI; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of central venous oxygen saturation (ScvO(2)) as a predictor of mortality in patients with sepsis. Ann Emerg Med. 2010 Jan;55(1):40-46.e1. doi: 10.1016/j.annemergmed.2009.08.014. Epub 2009 Oct 25.
PMID: 19854541
citation: Harilall Y, Adam JK, Biccard BM, Reddi A. Correlation between cerebral tissue and central venous oxygen saturation during off-pump coronary bypass graft surgery. Perfusion. 2011 Mar;26(2):83-90. doi: 10.1177/0267659110387846. Epub 2010 Nov 15.
PMID: 21078769
responsible party type: Sponsor
mesh term: Intraabdominal Infections
mesh term: Abdominal Neoplasms
sharing ipd: Yes