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

NCT ID: NCT05554978

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, placebo-controlled pilot trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
study drug preparation by a person not involved in patient recruitment and treatment

Study Groups

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Landiolol

initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total)

Group Type EXPERIMENTAL

Landiolol

Intervention Type DRUG

patient receives landiolol in addition to standard-of-care

Placebo

Sodium Chlorid 0,9%

Group Type PLACEBO_COMPARATOR

Sodium Chloride (NaCl) 0.9%

Intervention Type DRUG

Placebo

Interventions

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Landiolol

patient receives landiolol in addition to standard-of-care

Intervention Type DRUG

Sodium Chloride (NaCl) 0.9%

Placebo

Intervention Type DRUG

Other Intervention Names

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Onoact Rapibloc NaCl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Michael Holzer

Principal Investigator, Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael M Holzer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Georg Gelbenegger, MD

Role: CONTACT

+43140400 ext. 29810

Michael Holzer, MD

Role: CONTACT

+43140400 ext. 19640

Facility Contacts

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Georg Gelbenegger, MD

Role: primary

+43140400 ext. 29810

Bernd Jilma, Prof

Role: backup

+43140400 ext. 29810

Related Links

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http://klpharm.meduniwien.ac.at/

Department of Clinical Pharmacology

Other Identifiers

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Beta Blockade Cardiac Arrest

Identifier Type: -

Identifier Source: org_study_id

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