A Phase 1/2 interventional study of Landiolol and Sodium Chloride (NaCl) 0.9% in Cardiac Arrest, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by Medical University of Vienna · Phase 1/2, Interventional, and Treatment
This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm).
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 32 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total)
Drug: Landiolol
Sodium Chlorid 0,9%
Drug: Sodium Chloride (NaCl) 0.9%
patient receives landiolol in addition to standard-of-care
Also known as: Onoact, Rapibloc
Placebo
Also known as: NaCl
Time to sustained return of spontaneous circulation (sROSC)
time from bolus infusion of landiolol OR placebo to sROSC
Time frame: Time of sROSC or termination of resuscitation efforts
rate of sustained ROSC
number of sustained ROSC per included patients
Time frame: Time of sROSC or termination of resuscitation efforts
number of shocks until sROSC
number of shocks until sROSC per included patients
Time frame: Time of sROSC or termination of resuscitation efforts
rate of temporary ROSC (any ROSC)
number of temporary ROSC per included patients
Time frame: Time of sROSC or termination of resuscitation efforts
survival to ICU admission
how many patients survived to ICU admission
Time frame: Time of ICU admission or termination of resuscitation efforts
mean/median length of stay in ICU
in days
Time frame: Time of transfer to open ward or death
mean/median length of hospital stay
in days
Time frame: Time of hospital discharge or death
survival until hospital admission
how many patients were admitted alive to the hospital
Time frame: Time of hospital admission or death
survival until hospital discharge
how many patients survived to hospital discharge
Time frame: 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
Time frame: 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
Time frame: at hospital discharge, day 28, month 3, 6, 12
Plan to share: Yes — if requested, please address Georg Gelbenegger and Bernd Jilma
Supporting information: Study protocol, Sap, Icf, Csr
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna