Preventing Death and Severe Heart Rhythm Problems Using Amiodarone in Critically Ill Adults After Out-of-Hospital Cardiac Arrest with Shockable Rhythm

What this Trial Is About

Researchers are evaluating whether giving amiodarone for 72 hours can reduce deaths and severe heart rhythm problems within 30 days in critically ill adults admitted after an out-of-hospital cardiac arrest with an initial shockable heart rhythm and a confirmed or suspected cardiac cause. This phase 3 trial is randomized and compares patients receiving amiodarone to those receiving no intervention. The study is sponsored by Versailles Hospital. Participants in the amiodarone group receive an initial 300 mg loading dose over 30 minutes, followed by a continuous infusion for 72 hours at 10 mgkg per day, not exceeding 900 mg per 24 hours. The control group does not receive amiodarone. Treatment starts shortly after admission to intensive care and screening. The study measures outcomes for up to 90 days, including heart-related events, mortality, ventilation duration, neurological status, vasopressor use, and hospital stay length. During the study, patients are closely monitored in intensive care with regular assessments of their heart condition and overall health. Researchers track serious ventricular arrhythmias and death rates over 30 days as the main outcome. Secondary outcomes include longer-term cardiac events, neurological outcomes, and side effects related to amiodarone within 5 days. The total follow-up lasts up to 90 days, during which participants responses to treatment and safety are carefully observed.

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm