Correlation of VEGF-A and Fluid Balance in Septic Shock

NCT ID: NCT04474431

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2022-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients admitted in the ICU of hospital of Rouen

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

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Rouen

Rouen, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nell Marty

Role: CONTACT

02 32 88 82 65

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Déborah Boyer

Role: primary

02 32 88 82 61

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/0346/HP

Identifier Type: -

Identifier Source: org_study_id