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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest

• Study Type: Observational
• Enrollment (Actual): 452

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan
    • Hiroshima City Hospital
  • Osaka, Japan
    • Osaka City General Hospital
  • Osaka, Japan
    • Osaka Police Hospital
  • Osaka, Japan
    • Sumitomo Hospital
  • Saga, Japan
    • Saga University Hospital
  • Tokyo, Japan
    • Nihon University Surugadai Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
      • Kokura Memorial Hospital
  • Hokaido
    • Sapporo, Hokaido, Japan
      • Sapporo City University Hopistal
  • Kagawa
    • Takamatsu, Kagawa, Japan
      • Kagawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan
      • Yokohama City University Medical Center
  • Osaka
    • Suita, Osaka, Japan, 565-8565
      • National Cardiovascular Center
    • Suita, Osaka, Japan
      • Osaka Saiseikai Senri Hospital
    • Takatsuki, Osaka, Japan
      • Osaka Mishima Emergency Critical Care Center
  • Yamaguchi
    • Ube, Yamaguchi, Japan
      • Yamaguchi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
hypothermia; Patients with therapeutic hypothermia after cardiac arrest in hospitals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival and functional outcome (CPC: Cerebral Performance Categories)	after 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival and/or functional outcome	after 24 hours
Survival and/or functional outcome	after 7 days
Survival and/or functional outcome	after one month
Survival and/or functional outcome	at discharge
Survival or functional outcome	after three months

Collaborators and Investigators

• Sponsor: National Cerebral and Cardiovascular Center
• Investigators: Principal Investigator: Hiroshi Nonogi, MD, Department of Cardiology, National Cardiovascular Center , Japan

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 12, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: therapeutic hypothermia after cardiac arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Heart Arrest; Hypothermia
• Other Study ID Numbers: NCVC-JPULSE-H; UMIN000001935