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Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00901134
Acronym
J-PULSE-HYPO
Enrollment
452
Registered
2009-05-13
Start date
2008-06-30
Completion date
2011-07-31
Last updated
2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

therapeutic hypothermia after cardiac arrest

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.

Interventions

None listed

Sponsors

National Cerebral and Cardiovascular Center, Japan
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Survival and functional outcome (CPC: Cerebral Performance Categories)after 3 months

Secondary

MeasureTime frame
Survival and/or functional outcomeafter 24 hours
Survival or functional outcomeafter three months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026