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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05554978
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
33.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, double-blind, placebo-controlled pilot trialrandomized, double-blind, placebo-controlled pilot trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
study drug preparation by a person not involved in patient recruitment and treatment
Primary Purpose:
Treatment
Official Title:
Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial
Actual Study Start Date :
Mar 3, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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:
  • Onoact
  • Rapibloc

    		•
    Placebo Comparator: Placebo

    Sodium Chlorid 0,9%

    Drug: Sodium Chloride (NaCl) 0.9%
    Placebo
    Other Names:
  • NaCl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. rate of sustained ROSC [Time of sROSC or termination of resuscitation efforts]

      number of sustained ROSC per included patients

    2. number of shocks until sROSC [Time of sROSC or termination of resuscitation efforts]

      number of shocks until sROSC per included patients

    3. rate of temporary ROSC (any ROSC) [Time of sROSC or termination of resuscitation efforts]

      number of temporary ROSC per included patients

    4. survival to ICU admission [Time of ICU admission or termination of resuscitation efforts]

      how many patients survived to ICU admission

    5. mean/median length of stay in ICU [Time of transfer to open ward or death]

      in days

    6. mean/median length of hospital stay [Time of hospital discharge or death]

      in days

    7. survival until hospital admission [Time of hospital admission or death]

      how many patients were admitted alive to the hospital

    8. survival until hospital discharge [Time of hospital discharge or death]

      how many patients survived to hospital discharge

    9. 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

    10. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna Vienna Austria

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Michael Holzer, Principal Investigator, Professor of Emergency Medicine, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT05554978
    Other Study ID Numbers:
    • Beta Blockade Cardiac Arrest
    First Posted:
    Sep 26, 2022
    Last Update Posted:
    Sep 26, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Michael Holzer, Principal Investigator, Professor of Emergency Medicine, Medical University of Vienna
    cardiac arrest
    refractory
    ventricular fibrillation
    electrical storm
    landiolol
    Additional relevant MeSH terms:
    Heart Arrest
    Out-of-Hospital Cardiac Arrest
    Landiolol

    Study Results

    No Results Posted as of Sep 26, 2022