Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— Beta-Arrest  

Official title:

Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554978
• Other study ID #: Beta Blockade Cardiac Arrest
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 3, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: Georg Gelbenegger, MD
• Phone: +43140400
• Email: georg.gelbenegger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm).

Description:

The use of beta-blockers in OHCA patients with refractory VF could potentially reverse the unwanted beta-1-mediated effects of endogenous and exogenous epinephrine (proarrhythmic effect), which could in turn lead to a shorter time until return of spontaneous circulation (ROSC).

This is a prospective, double-blind, randomized placebo-controlled pilot trial. The investigators consider this a pilot trial, as this is the first prospective trial evaluating the use of beta-blockade in cardiac arrest.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• OHCA , >/=18 years of age

• 3 or more shockable rhythms (VF or pVT) and last rhythm shockable

Exclusion Criteria:

• Age > 85a

• Severe head trauma or acute active bleeding

• Known allergy or insensitivity to landiolol or another beta-blocker

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Drug:
• Landiolol
patient receives landiolol in addition to standard-of-care
• Sodium Chloride (NaCl) 0.9%
Placebo

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sustained return of spontaneous circulation (sROSC)	time from bolus infusion of landiolol OR placebo to sROSC	Time of sROSC or termination of resuscitation efforts
Secondary	rate of sustained ROSC	number of sustained ROSC per included patients	Time of sROSC or termination of resuscitation efforts
Secondary	number of shocks until sROSC	number of shocks until sROSC per included patients	Time of sROSC or termination of resuscitation efforts
Secondary	rate of temporary ROSC (any ROSC)	number of temporary ROSC per included patients	Time of sROSC or termination of resuscitation efforts
Secondary	survival to ICU admission	how many patients survived to ICU admission	Time of ICU admission or termination of resuscitation efforts
Secondary	mean/median length of stay in ICU	in days	Time of transfer to open ward or death
Secondary	mean/median length of hospital stay	in days	Time of hospital discharge or death
Secondary	survival until hospital admission	how many patients were admitted alive to the hospital	Time of hospital admission or death
Secondary	survival until hospital discharge	how many patients survived to hospital discharge	Time of hospital discharge or death
Secondary	favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)	measured by CPC and mRS	at hospital discharge, day 28, month 3, 6, 12
Secondary	survival at hospital discharge, day 28, month 3, 6, 12	how many patients survived to day 28, month 3, 6, 12	at hospital discharge, day 28, month 3, 6, 12

External Links

•   Department of Clinical Pharmacology