Study Overview
Official Title
Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest: A Cluster Randomized Trial (SAVE-J NEUROTHERM Trial)
Acronym
J-NEURO
Objective
The objective of this study is to evaluate the optimal target temperature for temperature control in post-resuscitation intensive care of patients who underwent extracorporeal cardiopulmonary resuscitation (ECPR) after out-of-hospital cardiac arrest (OHCA), by comparing survival rates, neurological outcomes, and adverse events between the hypothermia group and the normothermia group.
Design
Cluster-randomized crossover trial
Study Participants
Patients with OHCA who underwent ECPR
Inclusion Criteria
- OHCA, presumed internal (non-traumatic) cause
- Age of 18-75 years, known or estimated
- An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity
Arms and Interventions
Normothermia: Temperature control at 36 °C
Hypothermia: Temperature control at 33-34 °C
Outcome Measures
(1) Primary Outcome
- Survival at hospital discharge
(2) Secondary Outcomes
- Survival at 30 days, 90 days, and 1 year after admission
- Cerebral Performance Categories (CPC) at hospital discharge, 30 days, 90 days, and 1 year after admission
- Adverse events (arrhythmia, bleeding, pneumonia, and bloodstream infection)
Investigators
Principal Investigator: Akihiko Inoue, Hyogo Emergency Medical Center
Study Chair: Yasuhiro Kuroda, Kagawa University
Study Chair: Toru Hifumi, Kyorin University School of Medicine
Study Director: Tetsuya Sakamoto, Teikyo University
Study Director: Naoaki Ichihara, Osaka University