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NCT03968926: RetroECMO-VP

Hypotension During Extracorporeal Circulatory Support Indicated for Cardiogenic Shock

Status unknown Last updated 10 March 2020
What this trial tests

trial testing Arterial pressure management during circulatory support by VA-ECMO in Extracorporeal Life Support in 150 participants. Status unknown.

Timeline
30 June 2019
Primary endpoint
1 December 2020
30 December 2020

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment150
Start date30 June 2019
Primary completion1 December 2020
Estimated completion30 December 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 80, any sex, with Extracorporeal Life Support or Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The cardiogenic shock is characterized by an alteration of organs function following a decrease in cardiac output linked to an impairment of cardiac performance. The prognosis remains poor with mortality between 40 and 50%. Nowadays, Extracorporeal Life Support (ECLS or VA-ECMO) is the referent therapy to restore blood flow in the body when medical treatment is not sufficient. Despite a good blood flow provided by the ECLS, many patients develop a severe hypotension (so called vasoplegia) due to a loss of vascular resistance mainly explained by the inflammatory response to shock and extracorporeal circulation. The treatment of this reaction includes vasopressors (Norepinephrine in usual care) and serum surrogate perfusion to achieve a mean arterial pressure (MAP) above 65 mmHg. The purpose of this study is to describe the patients with vasoplegia among a retrospective cohort of patients treated with an ECLS in our university center, over the 4 last years, to determine major complication rate (including death, kidney failure and arrythmias) and their outcome. This study will provide consistent data useful for further trials about targets of pressure and treatments to increase blood pressure during ECLS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University Hospital, Montpellier trials

Trials by the same sponsor.

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