UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019510 |
|---|---|
| Receipt number | R000022529 |
| Scientific Title | The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients |
| Date of disclosure of the study information | 2015/10/27 |
| Last modified on | 2018/04/29 11:21:42 |
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Basic information
Public title
The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients
Acronym
The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients
Scientific Title
The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients
Scientific Title:Acronym
The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients
Region
| Japan |
Condition
Condition
Acute encephalitis and encephalopathy among pediatric patients
Classification by specialty
| Pediatrics | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if therapeutic hypothermia could be done as safely for acute encephalitis / encephalopathy of pediatric patients as that for another conditions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
If there occur any medical condition for which therapeutic hypothermia must be discontinued.
Key secondary outcomes
If there are seen more labo data, clinical signs, or monitored signs, that represent complications such as coagulopathy, infection, or worsened general conditions.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Therapeutic hypothermia (34 degree Celsius for 72 hours, followed by 48 hours of warming) using cooling pads.
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients less than 18 years old, who are diagnosed as acute encephalitis / encephalopathy, with no improvement or progressive worsening.
Acute encephalitis / encephalopathy would be diagnosed,when any findings as below are seen with no improvement within 3 hours:
1) acutely and moderately worsened consciousness level with JCS (Japan Coma Scale) more than 20,
2) mildly worsened consciousness level with JCS more than 10 lasting more than 24 hours,
3) accompanied with abnormal findings on head CT or head MRI, or
4) accompanied with abnormal EEG findings
Key exclusion criteria
Because coagulopathy are common during hypothermia,
(1-1) Intracranial hemorrhage was seen on head CT or MRI,
(1-2) Hemorrhagic diathesis, or
(1-3) thrombocytopenia less than 50,000/mm3.
Because immunosuppression are common during hypothermia,
(2-1) Congenital immunologic disability (SCID, a-gamma-globurinemia, chronic granulomatous disease, et.al).
Because circulation are easily suppressed during hypothermia,
(3-1) Cardiac disease or arrhythmia, which need medication.
(3-2) Decreased cardiac contractility (LVEF < 40% on echocardiogram)
(3-3) Normal blood pressure is not maintainable even with catecholamines or vasopressors.
Because this study needs informed consent from legal representatives,
(4-1) When legal representatives denied to be participated,
(4-2) When child abuse is strongly suspected,
Or whenever the regarding physicians thought the patient is not suitable for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Numaguchi |
Organization
Nagoya University Hospital
Division name
Department of emergency and critical care medicine
Zip code
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya City
TEL
052-744-2659
nummer@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Numaguchi |
Organization
Nagoya University Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya City
TEL
052-744-2659
Homepage URL
nummer@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Emergency and Critical Care Medicine, Nagoya 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 | 10 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
Management information
Registered date
| 2015 | Year | 10 | Month | 27 | Day |
Last modified on
| 2018 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022529
