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Correlation of VEGF-A and Fluid Balance in Septic Shock (VEGFluid)

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient above 18 years old
  • Patient with septic shock (presence of an infection, hypotension with mean arterial pressure less than 65mmHg and the need for vasopressor treatment (minimum dose 0,3µ/kg/min)
  • Person informed and signed consent.

Exclusion Criteria:

  • Death predicted within 24 hours
  • Limitation of therapeutic attitudes
  • Treatment with bevacizumab in the past 6 months
  • Pathologies with endothelial dysfunction (scleroderma, clarkson syndrome...)
  • Acute renal failure (KDIGO 3) at ICU admission defined by :
  • Increase in serum creatinine to > 354µmol/l or 3 times baseline OR
  • Urine output ≤0,3 ml/kg/h for 24h OR
  • Anuria for 12h
  • Morbid obesity with a body mass index (BMI) > 35 kg/m².
  • Limb amputation
  • Morbid obesity with a body mass index (BMI) > 35 kg/m².
  • Amputation of a limb
  • Pregnant or nursing women
  • Inability to obtain consent from family
  • Person with guardianship or curatorship

Sites / Locations

  • CHU de RouenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients admitted in the ICU of hospital of Rouen

Arm Description

Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.

Outcomes

Primary Outcome Measures

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.
Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D1 of ICU admission.

Secondary Outcome Measures

Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.
Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D3 of ICU admission.
Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.
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
Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.
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
Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.
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)
Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU
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
Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.
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.
Correlation of VEGF A levels at D1 and mortality at D28 of management.
Survival at D28 of ICU admission

Full Information

First Posted
June 25, 2020
Last Updated
October 30, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04474431
Brief Title
Correlation of VEGF-A and Fluid Balance in Septic Shock
Acronym
VEGFluid
Official Title
Correlation of VEGF-A and Fluid Balance in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 24, 2019 (Actual)
Primary Completion Date
January 24, 2022 (Anticipated)
Study Completion Date
January 24, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients admitted in the ICU of hospital of Rouen
Arm Type
Other
Arm Description
Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.
Intervention Type
Other
Intervention Name(s)
Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
Intervention Description
Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
Primary Outcome Measure Information:
Title
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.
Description
Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D1 of ICU admission.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.
Description
Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D3 of ICU admission.
Time Frame
3 days
Title
Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.
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
Time Frame
1 and 3 days
Title
Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.
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
Time Frame
1 and 3 days
Title
Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.
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)
Time Frame
1 and 3 days
Title
Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU
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
Time Frame
1 and 3 days
Title
Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.
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.
Time Frame
1 and 3 days
Title
Correlation of VEGF A levels at D1 and mortality at D28 of management.
Description
Survival at D28 of ICU admission
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient above 18 years old Patient with septic shock (presence of an infection, hypotension with mean arterial pressure less than 65mmHg and the need for vasopressor treatment (minimum dose 0,3µ/kg/min) Person informed and signed consent. Exclusion Criteria: Death predicted within 24 hours Limitation of therapeutic attitudes Treatment with bevacizumab in the past 6 months Pathologies with endothelial dysfunction (scleroderma, clarkson syndrome...) Acute renal failure (KDIGO 3) at ICU admission defined by : Increase in serum creatinine to > 354µmol/l or 3 times baseline OR Urine output ≤0,3 ml/kg/h for 24h OR Anuria for 12h Morbid obesity with a body mass index (BMI) > 35 kg/m². Limb amputation Morbid obesity with a body mass index (BMI) > 35 kg/m². Amputation of a limb Pregnant or nursing women Inability to obtain consent from family Person with guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nell Marty
Phone
02 32 88 82 65
Email
nell.marty@chu-rouen.fr
Facility Information:
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Déborah Boyer
Phone
02 32 88 82 61
Email
deborah.boyer@chu-rouen.fr

12. IPD Sharing Statement

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Correlation of VEGF-A and Fluid Balance in Septic Shock

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