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

NCT05554978 | Unknown Phase 1 DMC

• 1 other identifier: Beta Blockade Cardiac Arrest
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Arrest

Keywords

cardiac arrest; refractory; ventricular fibrillation; electrical storm; landiolol

Outcome Measures

Primary Outcomes (1)

• Time to sustained return of spontaneous circulation (sROSC)

  time from bolus infusion of landiolol OR placebo to sROSC

  Time of sROSC or termination of resuscitation efforts

Secondary Outcomes (10)

• rate of sustained ROSC

  Time of sROSC or termination of resuscitation efforts

• number of shocks until sROSC

  Time of sROSC or termination of resuscitation efforts

• rate of temporary ROSC (any ROSC)

  Time of sROSC or termination of resuscitation efforts

• survival to ICU admission

  Time of ICU admission or termination of resuscitation efforts

• mean/median length of stay in ICU

  Time of transfer to open ward or death

Study Arms (2)

Landiolol

EXPERIMENTAL

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

Drug: Landiolol

Placebo

PLACEBO COMPARATOR

Sodium Chlorid 0,9%

Drug: Sodium Chloride (NaCl) 0.9%

Interventions

Landiolol DRUG

patient receives landiolol in addition to standard-of-care

Also known as: Onoact, Rapibloc

Landiolol

Sodium Chloride (NaCl) 0.9% DRUG

Placebo

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OHCA , \>/=18 years of age
• or more shockable rhythms (VF or pVT) and last rhythm shockable

You may not qualify if:

• Age \> 85a
• Severe head trauma or acute active bleeding
• Known allergy or insensitivity to landiolol or another beta-blocker

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

Related Links

• Department of Clinical Pharmacology

MeSH Terms

Conditions

Heart Arrest; Ventricular Fibrillation

Interventions

landiolol; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael M Holzer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg Gelbenegger, MD

CONTACT

+43140400; georg.gelbenegger@meduniwien.ac.at

Michael Holzer, MD

CONTACT

+43140400; michael.holzer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: study drug preparation by a person not involved in patient recruitment and treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Emergency Medicine

Model Details: randomized, double-blind, placebo-controlled pilot trial

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: September 26, 2022
• Study Start: March 3, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after primary publication for 5 years

Locations

AU (1)