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

Primary Purpose

Cardiac Arrest

Status
Recruiting
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Landiolol
Sodium Chloride (NaCl) 0.9%
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, refractory, ventricular fibrillation, electrical storm, landiolol

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Landiolol

Placebo

Arm Description

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

Sodium Chlorid 0,9%

Outcomes

Primary Outcome Measures

Time to sustained return of spontaneous circulation (sROSC)
time from bolus infusion of landiolol OR placebo to sROSC

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2022
Last Updated
March 16, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05554978
Brief Title
Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest
Acronym
Beta-Arrest
Official Title
Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, refractory, ventricular fibrillation, electrical storm, landiolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled pilot trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
study drug preparation by a person not involved in patient recruitment and treatment
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Landiolol
Arm Type
Experimental
Arm Description
initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium Chlorid 0,9%
Intervention Type
Drug
Intervention Name(s)
Landiolol
Other Intervention Name(s)
Onoact, Rapibloc
Intervention Description
patient receives landiolol in addition to standard-of-care
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride (NaCl) 0.9%
Other Intervention Name(s)
NaCl
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to sustained return of spontaneous circulation (sROSC)
Description
time from bolus infusion of landiolol OR placebo to sROSC
Time Frame
Time of sROSC or termination of resuscitation efforts
Secondary Outcome Measure Information:
Title
rate of sustained ROSC
Description
number of sustained ROSC per included patients
Time Frame
Time of sROSC or termination of resuscitation efforts
Title
number of shocks until sROSC
Description
number of shocks until sROSC per included patients
Time Frame
Time of sROSC or termination of resuscitation efforts
Title
rate of temporary ROSC (any ROSC)
Description
number of temporary ROSC per included patients
Time Frame
Time of sROSC or termination of resuscitation efforts
Title
survival to ICU admission
Description
how many patients survived to ICU admission
Time Frame
Time of ICU admission or termination of resuscitation efforts
Title
mean/median length of stay in ICU
Description
in days
Time Frame
Time of transfer to open ward or death
Title
mean/median length of hospital stay
Description
in days
Time Frame
Time of hospital discharge or death
Title
survival until hospital admission
Description
how many patients were admitted alive to the hospital
Time Frame
Time of hospital admission or death
Title
survival until hospital discharge
Description
how many patients survived to hospital discharge
Time Frame
Time of hospital discharge or death
Title
favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)
Description
measured by CPC and mRS
Time Frame
at hospital discharge, day 28, month 3, 6, 12
Title
survival at hospital discharge, day 28, month 3, 6, 12
Description
how many patients survived to day 28, month 3, 6, 12
Time Frame
at hospital discharge, day 28, month 3, 6, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Gelbenegger, MD
Phone
+43140400
Ext
29810
Email
georg.gelbenegger@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Holzer, MD
Phone
+43140400
Ext
19640
Email
michael.holzer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael M Holzer, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Gelbenegger, MD
Phone
+43140400
Ext
29810
Email
georg.gelbenegger@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Bernd Jilma, Prof
Phone
+43140400
Ext
29810
Email
bernd.jilma@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
if requested, please address Georg Gelbenegger and Bernd Jilma
IPD Sharing Time Frame
2 years after primary publication for 5 years
Links:
URL
http://klpharm.meduniwien.ac.at/
Description
Department of Clinical Pharmacology

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

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