Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Completed

• Conditions: Cardiac Arrest

• Registration Number: NCT00901134
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

Brief Summary

Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Primary Completion: 2010-03
• Status Verified: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

• Adult patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest
• Presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS

Exclusion Criteria

• Patients with:

  • pregnancy
  • acute aortic dissection
  • pulmonary thromboembolism
  • drug poisoning
  • poor daily activity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival and functional outcome (CPC: Cerebral Performance Categories)	after 3 months

Secondary Outcome Measures

Name	Time	Method
Survival and/or functional outcome	at discharge
Survival or functional outcome	after three months

Trial Locations

Locations (14)

Kagawa University Hospital; 🇯🇵 Takamatsu, Kagawa, Japan

Yokohama City University Medical Center; 🇯🇵 Yokohama, Kanagawa, Japan

National Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan

Osaka Mishima Emergency Critical Care Center; 🇯🇵 Takatsuki, Osaka, Japan

Osaka Saiseikai Senri Hospital; 🇯🇵 Suita, Osaka, Japan

Osaka City General Hospital; 🇯🇵 Osaka, Japan

Osaka Police Hospital; 🇯🇵 Osaka, Japan

Sumitomo Hospital; 🇯🇵 Osaka, Japan

Saga University Hospital; 🇯🇵 Saga, Japan

Nihon University Surugadai Hospital; 🇯🇵 Tokyo, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Sapporo City University Hopistal; 🇯🇵 Sapporo, Hokaido, Japan

Yamaguchi University Hospital; 🇯🇵 Ube, Yamaguchi, Japan

Hiroshima City Hospital; 🇯🇵 Hiroshima, Japan