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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004502
Receipt No. 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

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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
Last 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
Email naito05084@gmail.com

Public contact
1st 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
Email naito05084@gmail.com

Sponsor
Institute Tsuyama Central Hospital Emergency and Critical Care Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005382

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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