Snake Antivenom Therapy for Improving Outcome in Russell\'s Viper Envenomation [SAVIOR] – Comparing the Efficacy and Safety of 36 Hours Regimen vs 72 Hours Regimen: A Randomized Controlled Trial

Background and aim: Half of all the snakebite deaths in the world occur in India.Russell's viper tops the killer list.The national guideline of antisnake venom therapy is not specific for Russell's viper.This study aimed to compare two dosing schedules in terms of efficacy and safety among Russell's viper envenomed patients.Patients and methods: This randomized controlled trial was conducted in a government, rural tertiary care hospital.Eligible patients were recruited based on predefined criteria and randomized to receive regimen 1 (100 mL ASV loading dose followed by 60 mL infusion every 6th hourly, maximum duration 36 hours) or regimen 2 (100 mL ASV loading followed by 20 mL 6th hourly, maximum duration 72 hours).Primary outcome studied was in-hospital mortality.Data was analyzed using SAS version 9.4 software (SAS Institute Inc., Cary, North Carolina, United States of America).Results: One hundred and sixty-two patients completed the study protocol.The overall mortality was 13.6%.There was higher in-hospital mortality in regimen 2 (17.2 vs 8.5%, p = 0.08).The median time for clinical recovery was faster in regimen 1 (48 vs 72 hours, p < 0.001).The patients in regimen 2 experienced significantly more complications such as acute kidney injury (AKI) (51.2 vs 23.2%, p < 0.001) and shock (30.0 vs 15.9%, p = 0.03).Both the regimens had matching safety profiles.Conclusion: Shorter, high intense regimen 1 produced clinically better results compared to spaced, low intense regimen 2 in terms of mortality and morbidity.The findings open up new frontiers to approach management of Russell's viper envenomation.Clinical trial registry number: CTRI/2022/12/048418 [Registered on