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

February 5, 2026 updated by: University Hospital, Rouen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Rouen, France
        • CHU de Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 days
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
1 and 3 days
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
1 and 3 days
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)
1 and 3 days
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
1 and 3 days
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.
1 and 3 days
Correlation of VEGF A levels at D1 and mortality at D28 of management.
Time Frame: 28 days
Survival at D28 of ICU admission
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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