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
About this trial
This is an interventional other trial for Septic Shock
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
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
NCT ID
NCT04474431
First Posted
June 25, 2020
Last Updated
October 30, 2020
Sponsor
University Hospital, Rouen
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
Learn more about this trial
Correlation of VEGF-A and Fluid Balance in Septic Shock
We'll reach out to this number within 24 hrs