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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03346824
Other study ID # 6946
Secondary ID
Status Recruiting
Phase N/A
First received November 14, 2017
Last updated February 23, 2018
Start date November 15, 2017
Est. completion date January 2019

Study information

Verified date November 2017
Source University Hospital, Strasbourg, France
Contact Gharib AJOB, MD
Phone 33 3 69 55 15 70
Email gharib.ajob@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. The aim of this study was to evaluate the benefit with levosimendan when used in weaning process.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age over 18

- Patient requiring the need for short-term assistance

- Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

- Refusal to participate in the study

- Non-weaning attempts due to a death under assistance or a relay by a long-term assistance or heart transplant

- Non-cardiac indications of assistance (indication of pulmonary replacement)

- Subject under guardianship or curatorship

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service Réanimation chirurgicale cardiovasculaire-NHC Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the incidence of weaning failure between patients with levosimendan and others Data were recorded from admission until 48 hours after weaning from ECMO
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