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NCT04938375 Clinical Trial

Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study

Cardiogenic Shock Clinical Trial

— SeLeBêta  

Official title:
Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04938375
Other study ID # 2021PI069
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date July 30, 2021

Study information
Verified date June 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date July 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment Exclusion Criteria: - Patient's opposition

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker Incidence of adverse events leading to discontinuation of beta blocker: bradycardia/high-grade atrioventricular block/hypotension/noradrenaline increase/crystalloid resuscitation From the start of the beta blocker until 7 days after the start of the Levosimendan treatment
Secondary Measure cardiac rhythm control; Measure heart rate control; Measure beta blocker dosages administered without adverse effects; Measure veno-arterial extra corporeal membranous oxygenation weaning rate; Measure resuscitation mortality Description of adverse events related to beta blocker Efficacy of beta blocker (rhythm and/or rate control) Time to resolution after discontinuation of beta blocker in case of adverse event Maximum dosage of well-tolerated beta blocker; Evolution of the haemodynamic profile in the hours following the introduction of the beta blocker Resuscitation mortality Weaning from veno-arterial ECMO at D7 of Levosimendan treatment From the start of the beta blocker until 7 days after the start of the Levosimendan treatment ; Haemodynamic changes will be recorded every 2 hours from the start of the beta blocker
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