UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004502 |
|---|---|
| Receipt number | R000005382 |
| Scientific Title | Changes in intracranial pressure during rewarming after therapeutic hypothermia. |
| Date of disclosure of the study information | 2010/11/04 |
| Last modified on | 2016/06/04 11:11:07 |
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Basic information
Public title
Changes in intracranial pressure during rewarming after therapeutic hypothermia.
Acronym
Changes in intracranial pressure during rewarming after therapeutic hypothermia.
Scientific Title
Changes in intracranial pressure during rewarming after therapeutic hypothermia.
Scientific Title:Acronym
Changes in intracranial pressure during rewarming after therapeutic hypothermia.
Region
| Japan |
Condition
Condition
Post-cardiac arrest syndrome
Classification by specialty
| Neurology | Neurosurgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the elevation in intracranial pressure during rewarming performed at the rate of 0.25 degrees C /h.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in intracranial pressure during rewarming.
Glasgow Coma Scale scores at 1 week after resuscitation.
Glasgow Pittsburgh cerebral performance categories and overall performance categories at 1 month after resuscitation.
Mortality rates at 1 month after resuscitation.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients resuscitated after out-of-hospital cardiac arrest.
2. Patients scheduled for therapeutic hypothermia after return of spontaneous circulation (indications: systolic blood pressure >= 90 mmHg, motor response on Glasgow coma scale <= 5, and at least one intact brain stem reflex).
3. Patients for whom intracranial pressure monitoring was required for assessing and treating brain edema until the rewarming.
Key exclusion criteria
1. Patients with hypotension (systolic blood pressure not maintained at >= 90 mmHg after resuscitation).
2. Patients without any brain stem reflex after resuscitation (i.e., pupils are dilated, light reflex is lost, and spontaneous breathing is absent).
3. Patients with intracranial space-occupying lesions(e.g., brain tumor, intracranial hematoma, and subarachnoid hemorrhage).
4. Patients who are pregnant.
5. Patients with immunodeficiency.
6. Rejection by the person with parental authority.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naito Hiromichi |
Organization
Tsuyama Central Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
1756 Kawasaki, Tsuyama City, Okayama Prefecture, Japan
TEL
0868-21-8111
naito05084@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naito Hiromichi |
Organization
Tsuyama Central Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
1756 Kawasaki, Tsuyama City, Okayama Prefecture, Japan
TEL
0868-21-8111
Homepage URL
naito05084@gmail.com
Sponsor or person
Institute
Tsuyama Central Hospital Emergency and Critical Care Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 11 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/27213805
Number of participants that the trial has enrolled
Results
Major ICP increases were observed in the rewarming period, after some increase in the mild TH period after CA, when TH was delivered in the range of the AHA Guidelines. ICP increment was greatest in patients with worse outcomes. ICP > 25 mmHg and CPP < 40 mmHg were associated with death in our series.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study was designed to evaluate the elevation of intracranial pressure during rewarming after therapeutic hypothermia performed at the rate of 0.25 degrees C /h.
Management information
Registered date
| 2010 | Year | 11 | Month | 04 | Day |
Last modified on
| 2016 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005382
| 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 |
