Clinical trial NCT00901134: Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan
Official title: Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: therapeutic hypothermia after cardiac arrest
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with therapeutic hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.

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.


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

Primary outcomes:
measure: Survival and functional outcome (CPC: Cerebral Performance Categories)
timeFrame: after 3 months
Secondary outcomes:
measure: Survival and/or functional outcome
timeFrame: after 24 hours
measure: Survival and/or functional outcome
timeFrame: after 7 days
measure: Survival and/or functional outcome
timeFrame: after one month
measure: Survival and/or functional outcome
timeFrame: at discharge
measure: Survival or functional outcome
timeFrame: after three months
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Sapporo City University Hopistal
state: Hokaido
city: Takamatsu
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Suita
country: Japan
facility: National Cardiovascular Center
state: Osaka
city: Suita
country: Japan
facility: Osaka Saiseikai Senri Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Mishima Emergency Critical Care Center
state: Osaka
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Osaka
country: Japan
facility: Sumitomo Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Tokyo
country: Japan
facility: Nihon University Surugadai Hospital
Study officials:
affiliation: Department of Cardiology, National Cardiovascular Center , Japan
name: Hiroshi Nonogi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.