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

Phase 1

Recruiting

• Conditions: Cardiac Arrest
• Interventions: Drug: Landiolol; Drug: Sodium Chloride (NaCl) 0.9%

• Registration Number: NCT05554978
• Lead Sponsor: Medical University of Vienna

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2021-03-03
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Landiolol	Landiolol	initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total)
Placebo	Sodium Chloride (NaCl) 0.9%	Sodium Chlorid 0,9%

Primary Outcome Measures

Name	Time	Method
Time to sustained return of spontaneous circulation (sROSC)	Time of sROSC or termination of resuscitation efforts	time from bolus infusion of landiolol OR placebo to sROSC

Secondary Outcome Measures

Name	Time	Method
rate of sustained ROSC	Time of sROSC or termination of resuscitation efforts	number of sustained ROSC per included patients
number of shocks until sROSC	Time of sROSC or termination of resuscitation efforts	number of shocks until sROSC per included patients
favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)	at hospital discharge, day 28, month 3, 6, 12	measured by CPC and mRS
survival at hospital discharge, day 28, month 3, 6, 12	at hospital discharge, day 28, month 3, 6, 12	how many patients survived to day 28, month 3, 6, 12
mean/median length of hospital stay	Time of hospital discharge or death	in days
survival until hospital admission	Time of hospital admission or death	how many patients were admitted alive to the hospital
rate of temporary ROSC (any ROSC)	Time of sROSC or termination of resuscitation efforts	number of temporary ROSC per included patients
survival to ICU admission	Time of ICU admission or termination of resuscitation efforts	how many patients survived to ICU admission
mean/median length of stay in ICU	Time of transfer to open ward or death	in days
survival until hospital discharge	Time of hospital discharge or death	how many patients survived to hospital discharge

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria