Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Cardiac Arrest Clinical Trial

— J-PULSE-HYPO  

Official title:

Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901134
• Other study ID #: NCVC-JPULSE-H
• Secondary ID: UMIN000001935
• Status: Completed
• Phase: N/A
• First received: May 12, 2009
• Last updated: July 21, 2011
• Start date: June 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: National Cerebral and Cardiovascular Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: July 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Locations

Country	Name	City	State
Japan	Hiroshima City Hospital	Hiroshima
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Osaka City General Hospital	Osaka
Japan	Osaka Police Hospital	Osaka
Japan	Sumitomo Hospital	Osaka
Japan	Saga University Hospital	Saga
Japan	Sapporo City University Hopistal	Sapporo	Hokaido
Japan	National Cardiovascular Center	Suita	Osaka
Japan	Osaka Saiseikai Senri Hospital	Suita	Osaka
Japan	Kagawa University Hospital	Takamatsu	Kagawa
Japan	Osaka Mishima Emergency Critical Care Center	Takatsuki	Osaka
Japan	Nihon University Surugadai Hospital	Tokyo
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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-hospita — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival and functional outcome (CPC: Cerebral Performance Categories)		after 3 months	Yes
Secondary	Survival and/or functional outcome		after 24 hours	Yes
Secondary	Survival and/or functional outcome		after 7 days	Yes
Secondary	Survival and/or functional outcome		after one month	Yes
Secondary	Survival and/or functional outcome		at discharge	Yes
Secondary	Survival or functional outcome		after three months	Yes

External Links

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