Cardiac Arrest
Conditions
Keywords
cardiac arrest, refractory, ventricular fibrillation, electrical storm, landiolol
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.
Interventions
DRUGLandiolol
patient receives landiolol in addition to standard-of-care
Placebo
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
study drug preparation by a person not involved in patient recruitment and treatment
Intervention model description
randomized, double-blind, placebo-controlled pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| number of shocks until sROSC | Time of sROSC or termination of resuscitation efforts | number of shocks until sROSC per included patients |
| rate of temporary ROSC (any ROSC) | Time of sROSC or termination of resuscitation efforts | number of temporary ROSC per included patients |
| survival to ICU admission | Time of ICU admission or termination of resuscitation efforts | how many patients survived to ICU admission |
| mean/median length of stay in ICU | Time of transfer to open ward or death | in days |
| rate of sustained ROSC | Time of sROSC or termination of resuscitation efforts | number of sustained ROSC per included patients |
| survival until hospital admission | Time of hospital admission or death | how many patients were admitted alive to the hospital |
| survival until hospital discharge | Time of hospital discharge or death | how many patients survived to hospital discharge |
| 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 |
| 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 |
| mean/median length of hospital stay | Time of hospital discharge or death | in days |
Countries
Austria
Contacts
Primary ContactGeorg Gelbenegger, MD
Backup ContactMichael Holzer, MD
Outcome results
None listed