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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Other: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Recruiting
    • CHU de ROUEN
    • Contact: Déborah Boyer; Phone Number: 02 32 88 82 61; Email: deborah.boyer@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients admitted in the ICU of hospital of Rouen; Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.	Other: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.; Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days
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	1 and 3 days
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	1 and 3 days
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)	1 and 3 days
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	1 and 3 days
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.	1 and 3 days
Correlation of VEGF A levels at D1 and mortality at D28 of management.	Survival at D28 of ICU admission	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Anticipated): January 24, 2022
• Study Completion (Anticipated): January 24, 2022

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 2018/0346/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No