Clinical trial NCT04474431: Correlation of VEGF-A and Fluid Balance in Septic Shock
Official title: Correlation of VEGF-A and Fluid Balance in Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 day
Secondary outcomes:
measure: Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.
timeFrame: 3 days
measure: Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.
timeFrame: 1 and 3 days
measure: Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.
timeFrame: 1 and 3 days
measure: Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.
timeFrame: 1 and 3 days
measure: Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU
timeFrame: 1 and 3 days
measure: Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.
timeFrame: 1 and 3 days
measure: Correlation of VEGF A levels at D1 and mortality at D28 of management.
timeFrame: 28 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References: