UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007615 |
|---|---|
| Receipt number | R000008969 |
| Scientific Title | A cluster randomized trial of duration of cooling in therapeutic hypothermia after resuscitation for cardiac arrest |
| Date of disclosure of the study information | 2012/03/31 |
| Last modified on | 2021/04/19 10:32:15 |
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Basic information
Public title
A cluster randomized trial of duration of cooling in therapeutic hypothermia after resuscitation for cardiac arrest
Acronym
J-PULSE-Hypo-DC trial
Scientific Title
A cluster randomized trial of duration of cooling in therapeutic hypothermia after resuscitation for cardiac arrest
Scientific Title:Acronym
J-PULSE-Hypo-DC trial
Region
| Japan |
Condition
Condition
Cardiac Arrest
Classification by specialty
| Cardiology | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study objective is to evaluate appropriate cooling duration (12-24 hours vs. 36 hours) in therapeutic hypothermia after resuscitation to cardiac arrest for incidence of complications within 1 months
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence proportion of complications within 1 month.
Definition of complications; infection, hemorrhage, Arrhythmia, decreasing blood pressure, shivering, convulsion and MACE(Major Adverse Cardiovascular Events) The evaluation of primary outcome is under blinded groups by Data Safety Monitoring Board
Key secondary outcomes
1) Proportion of death (within 24 hours, 7 days, 1 months, 3 months, at discharge)
2)Proportion of good neurological outcome (CPC: Cerebral Performance Categories) (within 24 hours, 7 days, 1 months, 3 months, at discharge)
3) Mortaliry rate
4) Incidence rate of complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Targeted cooling duration 12-24 hours in Therapeutic hypothermia
Interventions/Control_2
Targeted cooling duration 36 hours in Therapeutic hypothermia
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
1)Cardiac arrest
2)Stability of circulatory dynamics after ROSC(Return of spontaneous circulation) [including assisted with drug or auxiliary circulating pump]
3)Comatose state after ROSC
4)Adaptability status of therapeutic Hypothermia
Key exclusion criteria
Patients with:
Pregnancy
Acute aortic dissection
Pulmonary thromboembolism
Drug poisoning
Poor daily activity
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nonogi |
Organization
Shizuoka General Hospital
Division name
Hospital deputy
Zip code
Address
4-27-1, Kitaando, Aoi, Shizuoka, Shizuoka
TEL
054-247-6111
nonogijpulse@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yokoyama |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Cardiovascular Care Unit
Zip code
Address
5-7-1, Fujishirodai, Suita, Osaka
TEL
06-6833-5012(2231)
Homepage URL
http://j-pulse.umin.jp/
hiyokoyama@hsp.ncvc.go.jp
Sponsor or person
Institute
J-PULSE-Hypo investigators
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health and Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
国立循環器病研究センター,札幌医科大学,大阪市立総合医療センター,大阪警察病院,山口大学医学部附属病院先進救急医療センター,横浜市立大学附属市民総合医療センター、獨協医科大学附属病院、神戸市民医療センター中央市民病院、香川大学医学部付属病院、広島市民病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
185
Results
Tahara, Yoshio, et al. "A Cluster Randomized Trial of the Duration of Cooling in Therapeutic Hypothermia After Resuscitation for Cardiac Arrest." CIRCULATION. Vol. 134. No. 25. TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA: LIPPINCOTT WILLIAMS & WILKINS, 2016.
What has already been reported above is the conference abstract (international conference), and the final analysis is being submitted as a full paper. (April 19, 2021)
Results date posted
| 2021 | Year | 04 | Month | 19 | Day |
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
Main results already published
Date of protocol fixation
| 2011 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008969
