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The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients

The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients - The safety of therapeutic hypothermia for acute encephalitis / encephalopathy among pediatric patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019510
Enrollment
30
Registered
2015-10-27
Start date
2015-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute encephalitis and encephalopathy among pediatric patients

Interventions

Therapeutic hypothermia (34 degree Celsius for 72 hours, followed by 48 hours of warming) using cooling pads.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
If there occur any medical condition for which therapeutic hypothermia must be discontinued.

Secondary

MeasureTime frame
If there are seen more labo data, clinical signs, or monitored signs, that represent complications such as coagulopathy, infection, or worsened general conditions.

Countries

Japan

Contacts

Public ContactAtsushi Numaguchi

Nagoya University Hospital Department of Emergency and Critical Care Medicine

nummer@med.nagoya-u.ac.jp052-744-2659

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026