NCT03346824

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 27, 2018

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

November 14, 2017

Last Update Submit

February 23, 2018

Conditions

Cardiogenic Shock

Keywords

LevosimendanVeno-arterial ECMOWeaning

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who required the use of short-term assistance

You may qualify if:

  • Age over 18
  • Patient requiring the need for short-term assistance
  • Patient who has agreed to use his medical data for research purposes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service RĂ©animation chirurgicale cardiovasculaire-NHC

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Gharib AJOB, MD

CONTACT

33 3 69 55 15 70gharib.ajob@chru-strasbourg.fr

Guillaume HAFFNER, MD

CONTACT

33 3 69 55 15 70guillaume.haffner@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

November 15, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 27, 2018

Record last verified: 2017-11

Locations

FR(1)