Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus in Adults Admitted to Intensive Care Units: Protocol for a Double-Blind, Multicenter Randomized Controlled Trial

نویسندگان

چکیده

Background Generalized convulsive status epilepticus (GCSE) is a frequent medical emergency. GCSE treatment focuses on the administration of benzodiazepines followed by second-line antiepileptic drug (AED). Despite this stepwise strategy, not controlled in one-quarter patients and associated with protracted hospitalization, high mortality, long-term disability. Valproic acid (VPA) an AED good tolerability neuroprotective properties. Objective This study aims to demonstrate that VPA as adjuvant for first- can improve outcomes. Methods A multicenter, double-blind, randomized trial was conducted, comparing placebo adults admitted intensive care units (ICUs) France. diagnosed specifically trained ICU physicians according standard criteria. All received care, including benzodiazepine (not VPA), at discretion treating team. In intervention arm, administered intravenously loading dose 30 mg/kg over 15 minutes, continuous infusion 1 mg/kg/hour next 12 hours. group, identical intravenous 0.9% saline used. The primary outcome proportion discharged alive from hospital day 15. Secondary outcomes were frequency refractory super GCSE, ICU-related morbidity, adverse events related VPA, cognitive dysfunction 3 months. Statistical analyses will be performed intent-to-treat principle. Results first patient February 18, 2013, last July 7, 2018. Of 248 planned patients, 98.7% (245/248) enrolled across 20 ICUs. At present, data management still ongoing, all parties involved remain blinded. Conclusions Acid Adjuvant Treatment Convulsive Status Epilepticus (VALSE) evaluate whether use improves Trial Registration ClinicalTrials.gov NCT01791868; https://clinicaltrials.gov/ct2/show/NCT01791868. International Registered Report Identifier (IRRID) DERR1-10.2196/22511

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ژورنال

عنوان ژورنال: JMIR Research Protocols

سال: 2021

ISSN: ['1929-0748']

DOI: https://doi.org/10.2196/22511