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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003203
Receipt No. R000003881
Scientific Title Effectiveness of therapeutic hypothermia for unconscious adult patients with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest
Date of disclosure of the study information 2010/03/01
Last modified on 2012/09/04

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Basic information
Public title Effectiveness of therapeutic hypothermia for unconscious adult
patients with return of spontaneous circulation (ROSC) after
out-of-hospital cardiac arrest
Acronym Hypothermia first
Scientific Title Effectiveness of therapeutic hypothermia for unconscious adult
patients with return of spontaneous circulation (ROSC) after
out-of-hospital cardiac arrest
Scientific Title:Acronym Hypothermia first
Region
Japan

Condition
Condition cardiac arrest
Classification by specialty
Cardiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By the spread of cardiopulmonary resuscitation, the survival rate after cardiac arrest was improved. However, post cardiac arrest brain injury are not rare present. Only cardiopulmonary resuscitation was insufficient, cardio-pilmonary-cerebral resuscitation is important for cardiac arrest. In 2002, 2 randomized studies of mild therapeutic hypothermia after out-of-hospital cardiac arrest showed a neurological benefit with a low risk of complications, however, the optimal candidates, the procedure of cooling, the timing of initiation, target temperature, the therapeutic duration and the rate for rewarming have not been clearly defined and should be established. The purpose of this study was to evaluate the effect, limit of therapeutic hypothermia on the outcomes of patients with coma after resuscitation from out-of-hospital cardiac arrest.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a favorable neurological outcome at hospital discharge
(CPC: Cerebral Performance Categories)
Key secondary outcomes survival to hospital discharge or death

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 (1) aged 18 years and older, (2) a presumed cardiac origin of the arrest according to the Utstein Style reporting guidelines, (3) ROSC by standard CPR or/and ACLS, and (4) persistent coma after ROSC(GCS 3,4,5).
Key exclusion criteria (1) not cardiac origin, (2) tympanic-membrane temperature below 30degree on arrival at the emergency room, (3) cardiogenic shock after ROSC, (4) pregnancy, (5) the Glasgow-Pittsburgh overall performance category of 2 (moderate overall disability), 3 (severe overall disability), or 4 (vegetative state) before cardiac arrest, and (6) their families refused to give informed consent to participate in the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Nagao
Organization Surugadai Nihon University Hospital
Division name Department of resuscitation and emergency cardio-vascular unit
Zip code
Address 1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL 0332931711
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taketomo Soga
Organization Surugadai Nihon University Hospital
Division name Department of emergency medicine
Zip code
Address 1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL 0332931711
Homepage URL
Email

Sponsor
Institute Surugadai Nihon University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cohort study

Management information
Registered date
2010 Year 02 Month 17 Day
Last modified on
2012 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003881

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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