UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002224 |
|---|---|
| Receipt number | R000002682 |
| Scientific Title | Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device |
| Date of disclosure of the study information | 2009/07/31 |
| Last modified on | 2014/02/19 12:28:06 |
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Basic information
Public title
Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
Acronym
i-Cool
Scientific Title
Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
Scientific Title:Acronym
i-Cool
Region
| Japan |
Condition
Condition
Witnessed cardiac arrest(except cardiac arrest due to trauma)
Classification by specialty
| Cardiology | Neurology | Anesthesiology |
| Neurosurgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to elucidate the effects of pharyngeal cooling initiated during or immediately after resuscitation on tympanic temperature, neurological recovery and mortality rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time until tympanic temperature decreases by 1.0 degrees centigrade.
Glasgow Coma Scale at 2 weeks after resuscitation
Glasgow Pittsburgh cerebral performance and overall performance categories at 1 month and 6 months after resuscitation
Mortality rates at 1 month and 6 months after resuscitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients in the treatment group will undergo 2 hours of pharyngeal cooling during resuscitation or early after recovery of spontaneous circulation.
Interventions/Control_2
Patients in the control group will not undergo pharyngeal cooling during or after resuscitation.
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
| 16 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with witnessed cardiogenic cardiac arrest or witnessed non-cardiogenic cardiac arrest except posttraumatic cardiac arrest.
2. Patients who have been resuscitated by medical services within 15 min after the onset of cardiac arrest.
Key exclusion criteria
1. Patients with a disorder in the pharynx or esophagus.
2. Patients with severe hypothermia (less than 34 degrees centigrade upon arrival).
3. Patients who are pregnant.
4. Patients with an immunodeficiency or medicated with an immunosuppressant.
5. Patients with brain damage initiated by a mechanism other than cardiac arrest.
6. Rejection by a person in parental authority.
7. Score of Barthel index of less than 66.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Morita, MD, PhD |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name
Functional Physiology
Zip code
Address
2-5-1 Shikata-cho Okayama
TEL
81-86-235-7778
yoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Takeda, MD, PhD |
Organization
Okayama University Medical School
Division name
Anesthesiology & Resuscitology
Zip code
Address
2-5-1 Shikata-cho Okayama
TEL
81-86-235-7778
Homepage URL
http://www.cc.okayama-u.ac.jp/~cool/index.html
yoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.cc.okayama-u.ac.jp/~cool/protocol.html
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
| 2009 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 18 | Day |
Last modified on
| 2014 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002682
| 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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