Correlation of VEGF-A and Fluid Balance in Septic Shock

Septic Shock Clinical Trial

— VEGFluid  

Official title:

Correlation of VEGF-A and Fluid Balance in Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474431
• Other study ID #: 2018/0346/HP
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2019
• Est. completion date: January 24, 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: Nell Marty
• Phone: 02 32 88 82 65
• Email: nell.marty[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 24, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	3 days
Secondary	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	1 and 3 days
Secondary	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	1 and 3 days
Secondary	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)	1 and 3 days
Secondary	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	1 and 3 days
Secondary	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.	1 and 3 days
Secondary	Correlation of VEGF A levels at D1 and mortality at D28 of management.	Survival at D28 of ICU admission	28 days