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| Sponsor: | National Cardiovascular Center, Japan |
|---|---|
| Information provided by: | National Cardiovascular Center, Japan |
| ClinicalTrials.gov Identifier: | NCT00901134 |
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: | Cohort |
| Official Title: | Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan |
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated 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 |
Patients with therapeutic hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.
Inclusion Criteria:
Exclusion Criteria:
Patients with:
Contacts and Locations| Contact: Hiroshi Nonogi, MD | +81-6-6833-5004 ext 2233 | hnonogi@hsp.ncvc.go.jp |
| Japan | |
| Hiroshima City Hospital | Recruiting |
| Hiroshima, Japan | |
| Contact: Tastuya Maruhashi, MD maruchi@joy.ocn.ne.jp | |
| Principal Investigator: Tatsuya Maruhashi, MD | |
| Osaka Police Hospital | Recruiting |
| Osaka, Japan | |
| Contact: Kazunori Kashiwase, MD kassy@ohp.gr.jp | |
| Principal Investigator: Kazunori Kashiwase, MD | |
| Sumitomo Hospital | Not yet recruiting |
| Osaka, Japan | |
| Contact: Yasuga Yuji, MD yyasuga@gmail.com | |
| Principal Investigator: Yuji Yasuga, MD | |
| Osaka City General Hospital | Recruiting |
| Osaka, Japan | |
| Contact: Hideki Arimoto, MD arimoto-circ@umin.ac.jp | |
| Principal Investigator: Hideki Arimoto, MD | |
| Saga University Hospital | Recruiting |
| Saga, Japan | |
| Contact: Yuichi Motomura, MD d4402@cc.saga-u.ac.jp | |
| Principal Investigator: Tomokazu Motomura, MD | |
| Nihon University Surugadai Hospital | Recruiting |
| Tokyo, Japan | |
| Contact: Ken Nagao, MD kennagao@med.nihon-u.ac.jp | |
| Principal Investigator: Ken Nagao, MD | |
| Kitazato University Hospital | Not yet recruiting |
| Tokyo, Japan | |
| Contact: Kazui Soma, MD, PhD | |
| Principal Investigator: Kazui Soma, MD | |
| Japan, Fukuoka | |
| Kokura Memorial Hospital | Recruiting |
| Kitakyushu, Fukuoka, Japan | |
| Contact: Shinichi Shirai, MD s-sirai@db3.so-net.ne.jp | |
| Principal Investigator: Shinichi Shirai, MD | |
| Japan, Hokaido | |
| Sapporo City University Hopistal | Recruiting |
| Sapporo, Hokaido, Japan | |
| Contact: Mamoru Hase, MD hase@sapmed.ac.jp | |
| Principal Investigator: Mamoru Hase, MD | |
| Japan, Hyogo | |
| Kobe City Medical Center Genaral Hospital | Recruiting |
| Kobe, Hyogo, Japan | |
| Contact: Takuro Hayashi, MD takuro@kcgh.gr.jp | |
| Principal Investigator: Takuro Hayashi, MD | |
| Japan, Kagawa | |
| Kagawa University Hospital | Not yet recruiting |
| Takamatsu, Kagawa, Japan | |
| Contact: Yasuhiro Kuroda, MD | |
| Principal Investigator: Yasuhiro Kuroda, MD | |
| Japan, Kanagawa | |
| Yokohama City University Medical Center | Recruiting |
| Yokohama, Kanagawa, Japan | |
| Contact: Yoshio Tahara, MD tahara@urahp.yokohama-cu.ac.jp | |
| Principal Investigator: Yoshio Tahara, MD | |
| Japan, Osaka | |
| National Cardiovascular Center | Recruiting |
| Suita, Osaka, Japan, 565-8565 | |
| Contact: Hiroyuki Yokoyama, MD +81-6-6833-5012 hiyokoya@hsp.ncvc.go.jp | |
| Contact: Noriaki Kokubu, MD | |
| Principal Investigator: Hiroyuki Yokoyama, MD | |
| Sub-Investigator: Nobuaki Kokubu, MD | |
| Osaka Saiseikai Senri Hospital | Recruiting |
| Suita, Osaka, Japan | |
| Contact: Hirotaka Sawano, MD hsawano@senri.saiseikai.or.jp | |
| Principal Investigator: Hirotaka Sawano, MD | |
| Osaka Mishima Emergency Critical Care Center | Recruiting |
| Takatsuki, Osaka, Japan | |
| Contact: Hiroshi Hazui, MD hazui112@osaka-mishima.jp | |
| Principal Investigator: Hiroshi Hazui, MD | |
| Japan, Yamaguchi | |
| Yamaguchi University Hospital | Recruiting |
| Ube, Yamaguchi, Japan | |
| Contact: Shunji Kasaoka, MD skasa@yamaguchi-u.ac.jp | |
| Principal Investigator: Shunji Kasaoka, MD | |
| Principal Investigator: | Hiroshi Nonogi, MD | Department of Cardiology, National Cardiovascular Center , Japan |
More Information
| Responsible Party: | Department of Cardiology , National Cardiovascular Center,Japan ( Hiroshi Nonogi ) |
| Study ID Numbers: | NCVC-JPULSE-H, UMIN000001935 |
| Study First Received: | May 12, 2009 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00901134 History of Changes |
| Health Authority: | Japan: Institutional Review Board |
|
therapeutic hypothermia after cardiac arrest |
|
Signs and Symptoms Hypothermia Heart Diseases |
Cardiovascular Diseases Heart Arrest Body Temperature Changes |