Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

NCT ID: NCT00901134

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 452 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-07-31

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.

Conditions

Cardiac Arrest

Study Design

• Observational Model Type: COHORT

Study Groups

hypothermia

Patients with therapeutic hypothermia after cardiac arrest in hospitals

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role: lead

Responsible Party

Department of Cardiology , National Cardiovascular Center,Japan

Principal Investigators

Hiroshi Nonogi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, National Cardiovascular Center , Japan

Locations

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Hiroshima City Hospital

Hiroshima, Hiroshima, Japan

Sapporo City University Hopistal

Sapporo, Hokaido, Japan

Kagawa University Hospital

Takamatsu, Kagawa-ken, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

Osaka Police Hospital

Osaka, Osaka, Japan

Sumitomo Hospital

Osaka, Osaka, Japan

National Cardiovascular Center

Suita, Osaka, Japan

Osaka Saiseikai Senri Hospital

Suita, Osaka, Japan

Osaka Mishima Emergency Critical Care Center

Takatsuki, Osaka, Japan

Saga University Hospital

Saga, Saga-ken, Japan

Nihon University Surugadai Hospital

Tokyo, Tokyo, Japan

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Countries

Japan

References

Yokoyama H, Nagao K, Hase M, Tahara Y, Hazui H, Arimoto H, Kashiwase K, Sawano H, Yasuga Y, Kuroda Y, Kasaoka S, Shirai S, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Impact of therapeutic hypothermia in the treatment of patients with out-of-hospital cardiac arrest from the J-PULSE-HYPO study registry. Circ J. 2011;75(5):1063-70. doi: 10.1253/circj.cj-11-0137. Epub 2011 Apr 7.

Reference Type: RESULT

PMID: 21471669 (View on PubMed)

Soga T, Nagao K, Sawano H, Yokoyama H, Tahara Y, Hase M, Otani T, Shirai S, Hazui H, Arimoto H, Kashiwase K, Kasaoka S, Motomura T, Kuroda Y, Yasuga Y, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Neurological benefit of therapeutic hypothermia following return of spontaneous circulation for out-of-hospital non-shockable cardiac arrest. Circ J. 2012;76(11):2579-85. doi: 10.1253/circj.cj-12-0448. Epub 2012 Jul 20.

Reference Type: DERIVED

PMID: 22813874 (View on PubMed)

Related Links

http://j-pulse.umin.jp/

Related Info

Other Identifiers

UMIN000001935

Identifier Type: -

Identifier Source: secondary_id

NCVC-JPULSE-H

Identifier Type: -

Identifier Source: org_study_id