UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018229 |
|---|---|
| Receipt number | R000021100 |
| Scientific Title | Comparative analysis of hypothermia and controlled normothermia on neurological outcome following return of spontaneous circulation after out-of-hospital cardiac arrest |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2015/07/07 12:10:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparative analysis of hypothermia and controlled normothermia on neurological outcome following return of spontaneous circulation after out-of-hospital cardiac arrest
Acronym
Comparative analysis of hypothermia and normothermia on neurological outcome
Scientific Title
Comparative analysis of hypothermia and controlled normothermia on neurological outcome following return of spontaneous circulation after out-of-hospital cardiac arrest
Scientific Title:Acronym
Comparative analysis of hypothermia and normothermia on neurological outcome
Region
| Japan |
Condition
Condition
return of spontaneous circulation after out-of-hospital cardiac arrest
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to compare the influence of hypothermia or controlled normothermia on neurological outcome following return of spontaneous circulation after out-of-hospital cardiac arrest
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cereberal Performance Category on 28th day after admission
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Controlled normothermia
Interventions/Control_2
hypohtermia
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
Comatose patients (Glasgow Coma Scale <=8) whose spontaneous circulation was restored after out-of-hospital cardiac arrest
Key exclusion criteria
1.Possible causes of coma originated from brain (drug overdose, head trauma, or
cerebrovascular accident).
2.Core temperature below 30 degrees Celsius on admission
3.Patients with initial cardiac rhythm of asystole and with interval of more than 45 minutes from collapse to ROSC
4.Unstable circulation state after the return of spontaneous circulation and before randomization
5.Allergic to medicine which will be used in this study
6.Patients who are judged to be inappropriate for the study by the physician in charge
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yamamoto |
Organization
Osaka City University, Graduate School of Medicine
Division name
Department of Traumatology and Critical Care Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka City , 545-8585 Osaka, Japan
TEL
06-6645-3987
hyamamoto@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yamamoto |
Organization
Osaka City University, Graduate School of Medicine
Division name
Department of Traumatology and Critical Care Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka City , 545-8585 Osaka, Japan
TEL
06-6645-3987
Homepage URL
hyamamoto@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University, Graduate School of Medicine
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
| 2015 | Year | 07 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | 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
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2015 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
