Beta-blockade With Landiolol in Out-of-hospital Cardiac A... | NCT05554978

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

NCT05554978

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Mar 17, 2023Actual

Enrollment

32Estimated

Phase

Phase 1Phase 2

Conditions

Cardiac Arrest

Interventions

Landiolol
Sodium Chloride (NaCl) 0.9%

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2021Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Apr 19, 2022

First Submission Date that Met QC Criteria

Sep 22, 2022

First Posted Date

Sep 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Holzer, Principal Investigator, Professor of Emergency Medicine, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Landiolol	Drug	patient receives landiolol in addition to standard-of-care	Landiolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
rate of sustained ROSC	number of sustained ROSC per included patients	Time of sROSC or termination of resuscitation efforts
number of shocks until sROSC	number of shocks until sROSC per included patients

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georg Gelbenegger, MD	Contact	+43140400	29810	georg.gelbenegger@meduniwien.ac.at
Michael Holzer, MD	Contact	+43140400	19640	michael.holzer@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Michael M Holzer, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna			Austria

Label	URL
Department of Clinical Pharmacology	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

if requested, please address Georg Gelbenegger and Bernd Jilma

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

2 years after primary publication for 5 years

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	May 6, 2025
Reset	May 21, 2025

Submission Tracking

Estimated Results First Submitted Date

May 6, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 6, 2025			May 21, 2025

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C077049	landiolol
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided