Clinical trial NCT05554978: Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest
Official title: Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cardiac Arrest
Keywords: cardiac arrest
refractory
ventricular fibrillation
electrical storm
landiolol
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled pilot trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to sustained return of spontaneous circulation (sROSC)
timeFrame: Time of sROSC or termination of resuscitation efforts
Secondary outcomes:
measure: rate of sustained ROSC
timeFrame: Time of sROSC or termination of resuscitation efforts
measure: number of shocks until sROSC
timeFrame: Time of sROSC or termination of resuscitation efforts
measure: rate of temporary ROSC (any ROSC)
timeFrame: Time of sROSC or termination of resuscitation efforts
measure: survival to ICU admission
timeFrame: Time of ICU admission or termination of resuscitation efforts
measure: mean/median length of stay in ICU
timeFrame: Time of transfer to open ward or death
measure: mean/median length of hospital stay
timeFrame: Time of hospital discharge or death
measure: survival until hospital admission
timeFrame: Time of hospital admission or death
measure: survival until hospital discharge
timeFrame: Time of hospital discharge or death
measure: favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)
timeFrame: at hospital discharge, day 28, month 3, 6, 12
measure: survival at hospital discharge, day 28, month 3, 6, 12
timeFrame: at hospital discharge, day 28, month 3, 6, 12
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Michael M Holzer, MD
role: PRINCIPAL_INVESTIGATOR
References: