NCT00901134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

1.7 years

First QC Date

May 12, 2009

Last Update Submit

July 21, 2011

Conditions

Cardiac Arrest

Keywords

therapeutic hypothermia after cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Survival and functional outcome (CPC: Cerebral Performance Categories)

    after 3 months

Secondary Outcomes (5)

  • 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

Study Arms (1)

hypothermia

Patients with therapeutic hypothermia after cardiac arrest in hospitals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with:
  • pregnancy
  • acute aortic dissection
  • pulmonary thromboembolism
  • drug poisoning
  • poor daily activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Hiroshima City Hospital

Hiroshima, Hiroshima, Japan

Location

Sapporo City University Hopistal

Sapporo, Hokaido, Japan

Location

Kagawa University Hospital

Takamatsu, Kagawa-ken, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Location

Osaka City General Hospital

Osaka, Osaka, Japan

Location

Osaka Police Hospital

Osaka, Osaka, Japan

Location

Sumitomo Hospital

Osaka, Osaka, Japan

Location

National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Osaka Saiseikai Senri Hospital

Suita, Osaka, Japan

Location

Osaka Mishima Emergency Critical Care Center

Takatsuki, Osaka, Japan

Location

Saga University Hospital

Saga, Saga-ken, Japan

Location

Nihon University Surugadai Hospital

Tokyo, Tokyo, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Location

Related Publications (2)

  • 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.

    PMID: 21471669RESULT

  • 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.

    PMID: 22813874DERIVED

Related Links

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Hiroshi Nonogi, MD

    Department of Cardiology, National Cardiovascular Center , Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

June 1, 2008

Primary Completion

March 1, 2010

Study Completion

July 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

JP(14)