Correlation of VEGF-A and Fluid Balance in Septic Shock (NCT04474431) | Clinical Trial Compass
CompletedNot Applicable
Correlation of VEGF-A and Fluid Balance in Septic Shock
France103 participantsStarted 2019-12-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.