NCT04474431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

June 25, 2020

Last Update Submit

February 5, 2026

Conditions

Septic Shock

Outcome Measures

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.

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

    1 day

Secondary Outcomes (7)

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

    3 days

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

    1 and 3 days

  • Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.

    1 and 3 days

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

    1 and 3 days

  • Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU

    1 and 3 days

  • +2 more secondary outcomes

Study Arms (1)

Patients admitted in the ICU of hospital of Rouen

OTHER

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.

Interventions

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.

Patients admitted in the ICU of hospital of Rouen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rouen

Rouen, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 16, 2020

Study Start

December 24, 2019

Primary Completion

October 17, 2023

Study Completion

October 17, 2023

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

FR(1)