Development and Optimization of Anti snake venom dosing strategies in snakebite envenomated patients

The proposed study comprises two main phases aimed at enhancing the management of snakebite envenomation through an evidence-based approach. Phase I encompasses the development of a treatment model for Antivenom Serum (ASV) administration. Phase 1a consists of retrospective data collection to develop a model for ASV treatment strategy with respect to type of snakebite, clinical symptoms, lab parameters, and associated complications. All the data of patients admitted to our tertiary care hospital between 2017 to 2022, who were on therapy with ASV and satisfying the inclusion criteria will be considered for the study. A case report form (CRF) will be developed and validated by local experts for appropriateness, adequacy and relevance. Patient demographics, clinical signs, symptoms, daily laboratory parameters, details regarding snakebite if available, comorbidities, concomitant medications, complications, and outcomes such as ICU days, ventilation and hospitalization days, treatment provided (ASV and supportive therapy) and any adverse drug reactions due to ASV will be collected. Concurrently, in phase Ib, a comprehensive literature search will be performed that aims to identify and critically evaluate literature studies on clinical presentation, complications, management and outcomes of snakebite envenomation and ASV. Extensive literature search will be performed for the same in databases such as PubMed, Scopus, Science direct and Cochrane library to ensure comprehensive search strategy. Oxford criteria 2011 will be used for level of evidence from different type of study design. Quality of Randomized controlled trials (RCTs) would be assessed using Cochrane risk of bias assessment tool, observational studies using risk of bias in non-randomized studies of interventions (ROBINS-I). Methodological quality of included case report and case series will be assessed using tool developed by Murad et al.

Phase II consists of qualitative interview with the help of a validated interview guide regarding clinical experience with respect to managing of ASV dosing will be collected on a one-to-one basis through in-depth interviews in order to understand the current practice of ASV dosing by physicians. The conversations will be transcribed into verbatim using NVivo software. The themes generated from in-depth interview along with developed dosing strategy and literature review will be collectively presented through focus group discussion to the physicians. Any modifications suggested will be adopted to create a final version of practice-oriented dosing strategy of ASV and its efficacy and safety will be assessed. Subsequently, a prospective observational study will evaluate the efficacy and safety of the developed dosing strategy compared to existing practices. Patients from critical care medicine and emergency department who are diagnosed with snakebite envenomation and on therapy with ASV as defined above will be enrolled for the study by the principal investigator. An informed consent will be obtained from patient/ legally accepted representative after explanation of patient information sheet. Reconsenting from the patient will be done if the consent is taken from legally accepted representative after improvement of their condition. Patient demographics, clinical signs and symptoms, laboratory parameters, severity of disease, severity scores (such as SOFA, GCS and APACHE II score), comorbidities, concomitant nephrotoxic drugs, complications, ICU, ventilation and hospitalization days, other supportive therapy given will be collected through a validated CRF. Effectiveness of treatment with ASV will be assessed using a validated treatment effectiveness assessment tool which will include recovery/mortality, ventilation, oxygenation and hospitalization days, severity scores (baseline Vs time of discharge), laboratory parameters (baseline Vs time of discharge), and weaning of vasopressors. Safety would be assessed by monitoring for any adverse reactions due to ASV in patient.