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

Study Overview
=================
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.

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

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: Landiolol
* Drug: Sodium Chloride (NaCl) 0.9%


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled pilot trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Landiolol<br>initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total) | Drug: Landiolol<br>* patient receives landiolol in addition to standard-of-care<br>* Other names: Rapibloc;|
| Placebo Comparator: Placebo<br>Sodium Chlorid 0,9% | Drug: Sodium Chloride (NaCl) 0.9%<br>* Placebo<br>* 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 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 | 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 | Time of sROSC or termination of resuscitation efforts | 
| rate of temporary ROSC (any ROSC) | number of temporary ROSC per included patients | Time of sROSC or termination of resuscitation efforts | 
| survival to ICU admission | how many patients survived to ICU admission | Time of ICU admission or termination of resuscitation efforts | 
| mean/median length of stay in ICU | in days | Time of transfer to open ward or death | 
| mean/median length of hospital stay | in days | Time of hospital discharge or death | 
| survival until hospital admission | how many patients were admitted alive to the hospital | Time of hospital admission or death | 
| survival until hospital discharge | 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) | measured by CPC and mRS | at hospital discharge, day 28, month 3, 6, 12 | 
| survival 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, refractory, ventricular fibrillation, electrical storm, landiolol