UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001935 |
|---|---|
| Receipt number | R000002348 |
| Scientific Title | Multicenter registry study with therapeutic hypothermia after cardiac arrest in Japan |
| Date of disclosure of the study information | 2009/05/02 |
| Last modified on | 2010/08/17 13:15:44 |
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Basic information
Public title
Multicenter registry study with therapeutic hypothermia after cardiac arrest in Japan
Acronym
J-PULSE-HYPO study
Scientific Title
Multicenter registry study with therapeutic hypothermia after cardiac arrest in Japan
Scientific Title:Acronym
J-PULSE-HYPO study
Region
| Japan |
Condition
Condition
Cardiac Arrest
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, early defibrillation and 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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Survival and functional outcome (CPC: Cerebral Performance Categories) after 3 months
Key secondary outcomes
Survival and/or functional outcome after 24 hours, 7days, 1 months, 3 months, and at discharge
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with therapeutic
hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.
Inclusion criteria:
Adult (more than 18 years old) patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest and presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS.
Key exclusion criteria
Exclusion criteria: Patients with
pregnancy, acute aortic dissection,
pulmonary thromboembolism, drug
poisoning or poor daily activity
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nonogi |
Organization
National Cardiovascular Center
Division name
Department of Cardiology
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nonogi |
Organization
National Cardiovascular Center
Division name
Department of Cardiology
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
H19-Shinkin-03
The study for the establishment of the prehospital system in acute myocardial infarction and stroke
(J-PULSE2)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Multicenter registry study (retrospective and prospective cohort study)
Management information
Registered date
| 2009 | Year | 05 | Month | 02 | Day |
Last modified on
| 2010 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002348
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
