<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/NCT04474431</url>
  </required_header>
  <id_info>
    <org_study_id>2018/0346/HP</org_study_id>
    <nct_id>NCT04474431</nct_id>
  </id_info>
  <brief_title>Correlation of VEGF-A and Fluid Balance in Septic Shock</brief_title>
  <acronym>VEGFluid</acronym>
  <official_title>Correlation of VEGF-A and Fluid Balance in Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</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>
      VEGF is a key molecule in the control of vascular permeability via interactions with the&#xD;
      VEGF-receptor on the endothelial cell. Several authors reported plasma VEGF levels are&#xD;
      elevated in sepsis shock and associated with increased mortality (1,2).&#xD;
&#xD;
      In septic shock, the main elements of treatment are intravenous fluids, appropriate&#xD;
      antibiotics and vasopressors. Some authors observed positive fluid balance is associated with&#xD;
      increased mortality rates in patients (3,4).&#xD;
&#xD;
      To the best of our knowledge, no studies have shown a correlation between VEGF levels and the&#xD;
      fluid balance. The aim of our study was to determine the role of VEGF in capillary leakage&#xD;
      and the positive fluid balance in septic shock.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 24, 2019</start_date>
  <completion_date type="Anticipated">January 24, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 24, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Show that elevation of VEGF-A levels at D1 in the management of patients with septic shock is positively correlated with a positive fluid balance.</measure>
    <time_frame>1 day</time_frame>
    <description>Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D1 of ICU admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.</measure>
    <time_frame>3 days</time_frame>
    <description>Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D3 of ICU admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.</measure>
    <time_frame>1 and 3 days</time_frame>
    <description>Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: VEGF-A at D1 and D3 of ICU admission edema evaluation at D1 and D3 of ICU admission by:&#xD;
Weight&#xD;
fluid balance: difference between input (fluid therapy) and output (urine output)&#xD;
Ultrasound-measured thickness of subcutaneous tissue&#xD;
Measurement of total, intra and extra cellular body water evaluated by bioimpedancemetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.</measure>
    <time_frame>1 and 3 days</time_frame>
    <description>Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: sFlt1 at D1 and D3 of ICU admission edema evaluation at D1 and D3 of ICU admission by:&#xD;
Weight&#xD;
fluid balance: difference between input (fluid therapy) and output (urine output)&#xD;
Ultrasound-measured thickness of subcutaneous tissue&#xD;
Measurement of total, intra and extra cellular body water evaluated by bioimpedancemetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.</measure>
    <time_frame>1 and 3 days</time_frame>
    <description>Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: sFlt1&#xD;
- fluid balance: difference between input (fluid therapy) and output (urine output)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU</measure>
    <time_frame>1 and 3 days</time_frame>
    <description>Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: VEGF-A Study of microcirculation in vivo by Glycocheck: capillary density, Blood flow and red cell velocity, Endothelial glycocalyx function at D1 and D3 of ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.</measure>
    <time_frame>1 and 3 days</time_frame>
    <description>Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: VEGF-A and sFlt1 at D1 and D3 of their management in intensive care units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of VEGF A levels at D1 and mortality at D28 of management.</measure>
    <time_frame>28 days</time_frame>
    <description>Survival at D28 of ICU admission</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Patients admitted in the ICU of hospital of Rouen</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.</intervention_name>
    <description>Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.</description>
    <arm_group_label>Patients admitted in the ICU of hospital of Rouen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient above 18 years old&#xD;
&#xD;
          -  Patient with septic shock (presence of an infection, hypotension with mean arterial&#xD;
             pressure less than 65mmHg and the need for vasopressor treatment (minimum dose&#xD;
             0,3µ/kg/min)&#xD;
&#xD;
          -  Person informed and signed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Death predicted within 24 hours&#xD;
&#xD;
          -  Limitation of therapeutic attitudes&#xD;
&#xD;
          -  Treatment with bevacizumab in the past 6 months&#xD;
&#xD;
          -  Pathologies with endothelial dysfunction (scleroderma, clarkson syndrome...)&#xD;
&#xD;
          -  Acute renal failure (KDIGO 3) at ICU admission defined by :&#xD;
&#xD;
          -  Increase in serum creatinine to &gt; 354µmol/l or 3 times baseline OR&#xD;
&#xD;
          -  Urine output ≤0,3 ml/kg/h for 24h OR&#xD;
&#xD;
          -  Anuria for 12h&#xD;
&#xD;
          -  Morbid obesity with a body mass index (BMI) &gt; 35 kg/m².&#xD;
&#xD;
          -  Limb amputation&#xD;
&#xD;
          -  Morbid obesity with a body mass index (BMI) &gt; 35 kg/m².&#xD;
&#xD;
          -  Amputation of a limb&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Inability to obtain consent from family&#xD;
&#xD;
          -  Person with guardianship or curatorship&#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_contact>
    <last_name>Nell Marty</last_name>
    <phone>02 32 88 82 65</phone>
    <email>nell.marty@chu-rouen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Déborah Boyer</last_name>
      <phone>02 32 88 82 61</phone>
      <email>deborah.boyer@chu-rouen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT04474431
org study id: 2018/0346/HP
nct id: NCT04474431
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
VEGF is a key molecule in the control of vascular permeability via interactions with the
      VEGF-receptor on the endothelial cell. Several authors reported plasma VEGF levels are
      elevated in sepsis shock and associated with increased mortality (1,2).

      In septic shock, the main elements of treatment are intravenous fluids, appropriate
      antibiotics and vasopressors. Some authors observed positive fluid balance is associated with
      increased mortality rates in patients (3,4).

      To the best of our knowledge, no studies have shown a correlation between VEGF levels and the
      fluid balance. The aim of our study was to determine the role of VEGF in capillary leakage
      and the positive fluid balance in septic shock.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Show that elevation of VEGF-A levels at D1 in the management of patients with septic shock is positively correlated with a positive fluid balance.
time frame: 1 day
description: Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D1 of ICU admission.
measure: Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.
time frame: 3 days
description: Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D3 of ICU admission.
measure: Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.
time frame: 1 and 3 days
description: Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: VEGF-A at D1 and D3 of ICU admission edema evaluation at D1 and D3 of ICU admission by:
Weight
fluid balance: difference between input (fluid therapy) and output (urine output)
Ultrasound-measured thickness of subcutaneous tissue
Measurement of total, intra and extra cellular body water evaluated by bioimpedancemetry
measure: Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.
time frame: 1 and 3 days
description: Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: sFlt1 at D1 and D3 of ICU admission edema evaluation at D1 and D3 of ICU admission by:
Weight
fluid balance: difference between input (fluid therapy) and output (urine output)
Ultrasound-measured thickness of subcutaneous tissue
Measurement of total, intra and extra cellular body water evaluated by bioimpedancemetry
measure: Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.
time frame: 1 and 3 days
description: Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: sFlt1
- fluid balance: difference between input (fluid therapy) and output (urine output)
measure: Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU
time frame: 1 and 3 days
description: Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: VEGF-A Study of microcirculation in vivo by Glycocheck: capillary density, Blood flow and red cell velocity, Endothelial glycocalyx function at D1 and D3 of ICU admission
measure: Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.
time frame: 1 and 3 days
description: Plasma determination of endothelial dysfunction biomarkers by the enzyme-linked immunosorbent assay (ELISA) method: VEGF-A and sFlt1 at D1 and D3 of their management in intensive care units.
measure: Correlation of VEGF A levels at D1 and mortality at D28 of management.
time frame: 28 days
description: Survival at D28 of ICU admission
arm group label: Patients admitted in the ICU of hospital of Rouen
arm group type: Other
description: Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.
intervention type: Other
intervention name: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
description: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
arm group label: Patients admitted in the ICU of hospital of Rouen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nell Marty
phone: 02 32 88 82 65
email: nell.marty@chu-rouen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Shock