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NCT03968926: RetroECMO-VP
Hypotension During Extracorporeal Circulatory Support Indicated for Cardiogenic Shock
trial testing Arterial pressure management during circulatory support by VA-ECMO in Extracorporeal Life Support in 150 participants. Status unknown.
1 December 2020
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 30 June 2019 |
| Primary completion | 1 December 2020 |
| Estimated completion | 30 December 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Arterial pressure management during circulatory support by VA-ECMO
Conditions studied
- Extracorporeal Life Support — all drugs for Extracorporeal Life Support →
- Hypotension — all drugs for Hypotension →
- Vasoplegia — all drugs for Vasoplegia →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03968926 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 10 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03968926.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing