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

June 17, 2021 updated by: Central Hospital, Nancy, France
The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker
Time Frame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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