UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003203 |
|---|---|
| Receipt number | 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 08:42:29 |
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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
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
Sponsor or person
Institute
Surugadai Nihon University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
