Septic ShockVEGFluidNCT04474431
Correlation of VEGF-A and Fluid Balance in Septic Shock
A study testing Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance. in people with Septic Shock, run by University Hospital, Rouen at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2019to 17 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Septic Shock
- Being tested
- Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted in the ICU of hospital of Rouen | Other | Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen. Receives: Other: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 1 and 3 days
Correlation of VEGF A levels at D1 and mortality at D28 of management.
Survival at D28 of ICU admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start24 Dec 2019
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474431
- Sponsor's protocol ID
- 2018/0346/HP
- Acronym
- VEGFluid
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of VEGF-A and Fluid Balance in Septic Shock
- ClinicalTrials.gov ID
- NCT04474431
- Acronym / sponsor ID
- VEGFluid / 2018/0346/HP
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted in the ICU of hospital of Rouen | Other | Other: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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 :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients admitted in the ICU of hospital of Rouen |
Primary outcome
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.
7 secondary outcomes
Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.
Time frame: 3 days
Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.
Time frame: 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
Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.
Time frame: 1 and 3 days
Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU
Time frame: 1 and 3 days
Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.
Time frame: 1 and 3 days
Correlation of VEGF A levels at D1 and mortality at D28 of management.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance. in people with Septic Shock, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.