SAVE-J NEUROTHERM Trial

Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest: A Cluster Randomized Trial　　

Information

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

Participating Centers

  • Asahikawa Medical University Hospital
  • Ebina General Hospital
  • Hokkaido University Hospital
  • Hyogo Emergency Medical Center
  • Hyogo Prefectural Kakogawa Medical Center
  • Institute of Science Tokyo Hospital
  • Japanese Red Cross Musashino Hospital
  • Kagawa University Hospital
  • Keio University Hospital
  • Kurume University Hospital
  • Kyoto Second Red Cross Hospital
  • National Hospital Organization Disaster Medical Center
  • Nippon Medical School Hospital
  • Okayama University Hospital
  • Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
  • Osaka Saiseikai Senri Hospital
  • Oshima Prefectural Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Saitama Red Cross Hospital
  • Sapporo Medical University Hospital
  • Sendai Medical Center
  • St. Luke's International Hospital
  • Tohoku University Hospital
  • Tokyo Metropolitan Bokutoh Hospital
  • Tokyo Metropolitan Tama Medical Center
  • Tottori Prefectural Central Hospital
  • Toyooka Public Hospital
  • Tsuyama Chuo Hospital

Publications

  • In preparation