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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007615
Receipt No. 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 2017/04/04

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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
Email 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/
Email hiyokoyama@hsp.ncvc.go.jp

Sponsor
Institute J-PULSE-Hypo investigators
Institute
Department

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
Email

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 Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 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
2017 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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