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OpenTrials
Completed

NCT Number: NCT00901134

Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survival and functional outcome (CPC: Cerebral Performance Categories)

    Time frame: after 3 months

Secondary outcomes

  1. Survival and/or functional outcome

    Time frame: after 24 hours

  2. Survival and/or functional outcome

    Time frame: after 7 days

  3. Survival and/or functional outcome

    Time frame: after one month

  4. Survival and/or functional outcome

    Time frame: at discharge

  5. Survival or functional outcome

    Time frame: after three months

Sponsors and collaborators

Lead sponsor

National Cerebral and Cardiovascular Center, Japan

Other

Registry information

Acronym: J-PULSE-HYPO

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 13, 2009
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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