UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients
Title of the study (Brief title)	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	Atsushi Numaguchi
Organization	Nagoya University Hospital
Division name	Department of emergency and critical care medicine
Address	65 Tsurumai-Cho, Showa-Ku, Nagoya City
TEL	052-744-2659
Email	nummer@med.nagoya-u.ac.jp

Public contact
Name of contact person	Atsushi Numaguchi
Organization	Nagoya University Hospital
Division name	Department of Emergency and Critical Care Medicine
Address	65 Tsurumai-Cho, Showa-Ku, Nagoya City
TEL	052-744-2659
Homepage URL
Email	nummer@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Emergency and Critical Care Medicine, Nagoya University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022529