UMIN-CTR Clinical Trial

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

Cardiac Arrest

Classification by specialty

Cardiology	Emergency medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

J-PULSE-Hypo investigators

Institute

Department

Personal name

Organization

Ministry of Health and Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2012

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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