Full Text View
Tabular View
No Study Results Posted
Related Studies
Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan (J-PULSE-HYPO)
This study is currently recruiting participants.
Verified by National Cardiovascular Center, Japan, June 2009
First Received: May 12, 2009   Last Updated: June 11, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cardiovascular Center, Japan:

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Contacts
Contact: Hiroshi Nonogi, MD +81-6-6833-5004 ext 2233 hnonogi@hsp.ncvc.go.jp

Locations
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            
Sponsors and Collaborators
National Cardiovascular Center, Japan
Investigators
Principal Investigator: Hiroshi Nonogi, MD Department of Cardiology, National Cardiovascular Center , Japan
  More Information

No publications provided

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

Keywords provided by National Cardiovascular Center, Japan:
therapeutic hypothermia after cardiac arrest

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

ClinicalTrials.gov processed this record on February 08, 2010