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NCT Number: NCT04474431

Correlation of VEGF-A and Fluid Balance in Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rouen

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.

Other

Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.

    Time frame: 3 days

    Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D3 of ICU admission.

  2. Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.

    Time frame: 1 and 3 days

    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

  3. 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

    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

  4. Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.

    Time frame: 1 and 3 days

    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)

  5. Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU

    Time frame: 1 and 3 days

    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

  6. Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.

    Time frame: 1 and 3 days

    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.

  7. Correlation of VEGF A levels at D1 and mortality at D28 of management.

    Time frame: 28 days

    Survival at D28 of ICU admission

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: VEGFluid

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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