Levosimendan Efficacy for Veno-arterial ECMO Weaning: a R... | NCT03346824

Studies
Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study

NCT03346824

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Feb 27, 2018Actual

Enrollment

65Estimated

Phase

Not provided

Conditions

Cardiogenic Shock

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2017Actual

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Nov 14, 2017

First Submission Date that Met QC Criteria

Nov 16, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2018

Last Update Posted Date

Feb 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient who required the use of short-term assistance

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gharib AJOB, MD	Contact	33 3 69 55 15 70		gharib.ajob@chru-strasbourg.fr
Guillaume HAFFNER, MD	Contact	33 3 69 55 15 70		guillaume.haffner@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Réanimation chirurgicale cardiovasculaire-NHC	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided