Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion
Conditions
Interventions
The intervention group: RIPoC (4 cycles of 5 mins inflation and 5 mins deflation) is applied on a lower extremity using a blood pressure monitor cuff with 200 mmHg at the initiation of targeted temper
Sponsors
Social Medical Corporation Yuki no Seibokai , St. Mary's Research Cente
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pediatric patients (1month-15years) fulfilling the diagnostic criteria of AESD or paediatric patients with persistent consciousness disturbance more than 6 hours after early seizure/seizures strongly suggestive for AESD judging from clinical symptoms/signs (seizures and consciousness disturbance) and electroencephalogram findings (usually generalised high voltage slow wave) and later confirmed as AESD by the neuroimaging
Exclusion criteria
Exclusion criteria: Exclusion criteria for applying RIPoC were patients who the consent is not gained from their parent/parents or guardians for the study, patients with thrombocytopenia (<100,000/uL), coagulation disorders (international normalised ratio of prothrombin time > 1.89 s or activated partial thromboplastin time > 508.5s), patients with shock, or unstable hemodynamic status with elevated intracranial hypertension symptoms, requiring catecholamine medications or antihypertensive medications, and patients with injuries or skin inflammation on both lower extremities which prevent the application of a blood pressure monitor cuff. Patient who underwent therapeutic hypothermia due to persistent consciousness disturbance more than 6 hours after ES/ESs, which was strongly suggestive for AESD, but later revealing no abnormal MRI or SPECT findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological outcomes evaluated by psychologists who do not know the treatment assignment at the time of one, three, six, twelve months and three years from the onset are compared between the two groups using below three methods. 1. When the patient age is less than 18 months at the time of evaluation, the Kyoto Scale of Psychological Development 2001 (KSPD) is used for the evaluation. When the patient age is 18 months or more, Tanaka-Binet Intelligence Scale is used. 2. The evaluation is also made using Vineland Adaptive Behavior Scales, Second Edition at six, twelve months and three years from the onset. 3. Pediatric Cerebral Performance Category Scale (PCPC) judging from above two neurological assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective evaluation of autonomic nervous system 1. Comparison changes in cortisol, melatonin, and Chromogranin A in saliva between the two groups at 6 points a day (6, 10, 12, 15, 17, 21:00) for three days plus before and three hours after the RIPoC procedure on the first day and third day. 2. Comparison of low frequency, high frequency, and LF/FH ratio for three days from the start of therapeutic temperature management between the two groups using Holter electrocardiographic monitoring | — |
Countries
Japan
Contacts
Public ContactGo Kawano
St Marys Hospital Department of Paediatrics
Outcome results
None listed