UMIN-CTR Clinical Trial

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