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

University Hospital, Rouen

Status: Unknown

Conditions: Septic Shock

Treatments: Other: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.

Study type: Interventional

Funder types: Other

Identifiers

NCT04474431

2018/0346/HP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients admitted in the ICU of hospital of Rouen

Other group

Description:

Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.

Treatment:

Other: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.