UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059215 |
|---|---|
| Receipt number | R000066857 |
| Scientific Title | Efficacy of Remote Ischaemic Postconditioning in Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion: randomised control trial |
| Date of disclosure of the study information | 2025/09/28 |
| Last modified on | 2025/09/27 14:49:13 |
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Basic information
Public title
Efficacy of Remote Ischaemic Postconditioning in Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion
Acronym
Efficacy of RIPoC in AESD
Scientific Title
Efficacy of Remote Ischaemic Postconditioning in Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion: randomised control trial
Scientific Title:Acronym
Efficacy of RIPoC in AESD
Region
| Japan |
Condition
Condition
Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion
Classification by specialty
| Neurology | Pediatrics | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prospectively investigate the efficacy of remote iscaemic postconditiong (RIPoC) as an adjunct therapy to therapeutic hypothermia in AESD patients by comparing the outcomes between AESD patients with targeted temperature management (34 degrees celsius) and those with targeted temperature management and RIPoC.
Basic objectives2
Others
Basic objectives -Others
We also investigate the effect of RIPoC on autonomic nervous system under targeted temperature management (34 degrees celsius)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
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 temperature management for 72 hours. Briefly, after a patient is intubated, arterial blood pressure monitoring is established at an upper extremity, and targeted temperature management (34 degrees celsiu) is initiated, a blood pressure monitor cuff is placed on another upper extremity and both side of thighs. The cuff is inflated to 200mmHg and the artery is checked whether to be occluded completely using the ultrasonic blood flowmeter and/or colour doppler image by ultrasonography. During each interval of cuff inflation, the pulse is checked peripherally to the site where the cuff is applied using the ultrasonic blood flowmeter and also skin damage to the site, such as swelling, redness, is checked using the ultrasonic blood flowmeter and colour doppler image by ultrasonography. During the 40 minutes of the procedure, blood pressure, heart rate, oxygen aturation, are checked every minute. Blood samples for coagulation function test was taken from patients at two timepoints, just before the procedure and after the 5 cycles of RIPoC, and PT, APTT was compared between them. These procedures are repeated every 24 hours for three days.
Interventions/Control_2
After a patient is intubated, arterial blood pressure monitoring is established at an upper extremity, and targeted temperature management (34 degrees celsiu) for 72 hours is initiated.
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
| 1 | months-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key 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
Key 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 > 1.3 s or activated partial thromboplastin time > 50 s), 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.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Kawano |
Organization
St Marys Hospital
Division name
Department of Paediatrics
Zip code
830-8543
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
TEL
0942-35-3322
kawano19720625@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Kawano |
Organization
St Marys Hospital
Division name
Department of Paediatrics
Zip code
830-8543
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
TEL
0942-35-3322
Homepage URL
https://www.st-mary-med.or.jp/hospital/optout.html
kawano19720625@yahoo.co.jp
Sponsor or person
Institute
Social Medical Corporation Yuki no Seibokai , St. Mary's Research Cente
Institute
Department
Personal name
Go Kawano
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Yuki no Seibokai , St. Mary's Research Cente
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
Tel
0942-36-2250
kenkyusyo@st-mary-med.or.jp
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
| 2025 | Year | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066857
