Status:
COMPLETED
LEVOSIMENDAN to Facilitate Weaning From ECMO in Severe Cardiogenic Shock Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cardiogenic Shock
Extracorporeal Membrane Oxygenation Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In the last decade, venoarterial extracorporeal membrane oxygenation (VA-ECMO) has become the first-line therapy in patients with refractory cardiogenic shock. VA-ECMO provides both respiratory and ca...
Eligibility Criteria
Inclusion
- Acute cardiogenic shock patient refractory to conventional therapy placed on VA-ECMO support in the preceding 48h.
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed. Close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Exclusion
- Age \<18
- Pregnant or lactating women
- Initiation of VA-ECMO \>48 h
- Resuscitation \>30 minutes in the 48 hours before ECMO (cumulative low-flow time). If a low-flow episode occurs before the 48 hours window prior to ECMO, patients must fully recover consciousness to be randomized.
- Irreversible neurological pathology
- End-stage cardiomyopathy with no hope of LV function recovery
- Mechanical complication of myocardial infarction
- Aortic regurgitation \> II
- VA-ECMO for pulmonary embolism
- VA-ECMO for cardiotoxic drug intoxication
- ECMO after left-ventricle assist device implantation
- VA-ECMO in heart transplant patients
- Patient moribund on the day of randomization, SAPS II \>90
- Liver cirrhosis (Child B or C) and other severe hepatic insufficiency
- Chronic renal failure requiring hemodialysis
- Known hypersensitivity to levosimendan
- History of torsades de pointes in the 30 days prior to inclusion
- History of epilepsy
- Individuals under guardianship, or permanently legally incompetent adults
- Participation to another interventional study
- Patient with a weight over 180 kg
- Known hypersensitivity to polyvitamin CERNEVIT®
- In case of hypervitaminosis to any vitamin contained in this formulation,
- In case of severe hypercalcemia, hypercalciuria, treatment, pathology and/or disorders leading to severe hypercalcemia and/or hypercalciuria
- In combination with vitamin A or retinoids
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04728932
Start Date
August 27 2021
End Date
November 9 2024
Last Update
March 21 2025
Active Locations (3)
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1
Hôpital du Haut-Lévêque
Pessac, Bordeaux, France
2
Hôpital Pitié Salpêtrière
Paris, France, 75013
3
Hôpital Européen Georges Pompidou
Paris, France