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

March 16, 2023 updated by: Michael Holzer, Medical University of Vienna

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Landiolol
initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total)
Drug: Landiolol
patient receives landiolol in addition to standard-of-care
Other Names:
  • Rapibloc
  • Onoact
Placebo Comparator: Placebo
Sodium Chlorid 0,9%
Drug: Sodium Chloride (NaCl) 0.9%
Placebo
Other Names:
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to sustained return of spontaneous circulation (sROSC)
Time Frame: Time of sROSC or termination of resuscitation efforts
time from bolus infusion of landiolol OR placebo to sROSC
Time of sROSC or termination of resuscitation efforts

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael M Holzer, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beta Blockade Cardiac Arrest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

if requested, please address Georg Gelbenegger and Bernd Jilma

IPD Sharing Time Frame

2 years after primary publication for 5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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