Clinical Trial: Efficacy of Remote Ischaemic Postconditioning in Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion: randomised control trial (Japan)

Tokyo, Sept. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059215) titled 'Efficacy of Remote Ischaemic Postconditioning in Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion' on Sept. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Social Medical Corporation Yuki no Seibokai , St. Mary's Research Cente

Condition: Condition - Acute Encephalopathy with Biphasic Seizures and Late Reduced Diffusion Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 1 months-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 ( 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 Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 21 Day Anticipated trial start date - 2025 Year 07 Month 22 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066857

Disclaimer: Curated by HT Syndication.