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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04938375

Acronym

SeLeBêta

Enrollment

Registered

2021-06-24

Start date

2016-01-01

Completion date

2021-07-30

Last updated

2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia, Cardiogenic Shock

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker	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

Secondary

Measure	Time frame	Description
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	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

Outcome results