Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-24 @ 9:27 PM
NCT ID:
NCT04728932
Eligibility Criteria:
Inclusion Criteria:
1. Acute cardiogenic shock patient refractory to conventional therapy placed on VA-ECMO support in the preceding 48h.
2. 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 Criteria:
1. Age \<18
2. Pregnant or lactating women
3. Initiation of VA-ECMO \>48 h
4. 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.
5. Irreversible neurological pathology
6. End-stage cardiomyopathy with no hope of LV function recovery
7. Mechanical complication of myocardial infarction
8. Aortic regurgitation \> II
9. VA-ECMO for pulmonary embolism
10. VA-ECMO for cardiotoxic drug intoxication
11. ECMO after left-ventricle assist device implantation
12. VA-ECMO in heart transplant patients
13. Patient moribund on the day of randomization, SAPS II \>90
14. Liver cirrhosis (Child B or C) and other severe hepatic insufficiency
15. Chronic renal failure requiring hemodialysis
16. Known hypersensitivity to levosimendan
17. History of torsades de pointes in the 30 days prior to inclusion
18. History of epilepsy
19. Individuals under guardianship, or permanently legally incompetent adults
20. Participation to another interventional study
21. Patient with a weight over 180 kg
22. Known hypersensitivity to polyvitamin CERNEVIT®
23. In case of hypervitaminosis to any vitamin contained in this formulation,
24. In case of severe hypercalcemia, hypercalciuria, treatment, pathology and/or disorders leading to severe hypercalcemia and/or hypercalciuria
25. In combination with vitamin A or retinoids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04728932
Study Brief:
Protocol Section:
NCT04728932