Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan (J-PULSE-HYPO)

This study has been completed.
Sponsor:
Information provided by:
National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT00901134
First received: May 12, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Resource links provided by NLM:


Further study details as provided by National Cerebral and Cardiovascular Center:

Primary Outcome Measures:
  • Survival and functional outcome (CPC: Cerebral Performance Categories) [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival and/or functional outcome [ Time Frame: after 24 hours ] [ Designated as safety issue: Yes ]
  • Survival and/or functional outcome [ Time Frame: after 7 days ] [ Designated as safety issue: Yes ]
  • Survival and/or functional outcome [ Time Frame: after one month ] [ Designated as safety issue: Yes ]
  • Survival and/or functional outcome [ Time Frame: at discharge ] [ Designated as safety issue: Yes ]
  • Survival or functional outcome [ Time Frame: after three months ] [ Designated as safety issue: Yes ]

Enrollment: 452
Study Start Date: June 2008
Study Completion Date: July 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
hypothermia
Patients with therapeutic hypothermia after cardiac arrest in hospitals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with therapeutic hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901134

Locations
Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Sapporo City University Hopistal
Sapporo, Hokaido, Japan
Kagawa University Hospital
Takamatsu, Kagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Osaka Saiseikai Senri Hospital
Suita, Osaka, Japan
Osaka Mishima Emergency Critical Care Center
Takatsuki, Osaka, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Hiroshima City Hospital
Hiroshima, Japan
Osaka Police Hospital
Osaka, Japan
Sumitomo Hospital
Osaka, Japan
Osaka City General Hospital
Osaka, Japan
Saga University Hospital
Saga, Japan
Nihon University Surugadai Hospital
Tokyo, Japan
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Investigators
Principal Investigator: Hiroshi Nonogi, MD Department of Cardiology, National Cardiovascular Center , Japan
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroshi Nonogi, Department of Cardiology , National Cardiovascular Center,Japan
ClinicalTrials.gov Identifier: NCT00901134     History of Changes
Other Study ID Numbers: NCVC-JPULSE-H, UMIN000001935
Study First Received: May 12, 2009
Last Updated: July 21, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by National Cerebral and Cardiovascular Center:
therapeutic hypothermia after cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014