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CTRI Number  CTRI/2024/05/067306 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Adjustment of antisnake venom dose in snake bite poisoning 
Scientific Title of Study   Development and Optimization of Anti snake venom dosing strategies in snakebite envenomated patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayaraj Mymbilly Balakrishnan 
Designation  Professor and Head Department of Emergency Medicine  
Affiliation  Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka 
Address  Department of Emergency medicine Kasturba Medical College Manipal Academy of Higher Education Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  jayaraj.mb@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Girish Thunga 
Designation  Associate Professor, Department of Pharmacy Practice 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka 
Address  Department of Pharmacy Practice Manipal College of Pharmaceutical Sciences Manipal Academy of Higher Education Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Girish Thunga 
Designation  Associate Professor, Department of Pharmacy Practice 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka 
Address  Department of Pharmacy Practice Manipal College of Pharmaceutical Sciences Manipal Academy of Higher Education Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayaraj Mymbilly Balakrishnan  Kasturba Medical College  Room no-4, Department of Emergency Medicine, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA 
9895063580

jayaraj.mb@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T630||Toxic effect of snake venom,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients (aged ≥18 years) irrespective of
gender and admitted to the hospital with snake bite envenomation and on therapy with ASV. 
 
ExclusionCriteria 
Details  1.Patients who were managed with supportive therapy alone 2. Patients referred from other centres with the history of snakebites with concomitant hospital acquired infections. 3.Patients with history of snakebite more than 10 days and referred for further management. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Primary outcome is the effectiveness of ASV treatment dosing in terms of recovery/mortality
 
Assessment done at 2 time points: Time of enrollment and at the time of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of
-ventilation
-oxygenation
-hospitalization days
-severity scores
-laboratory parameters
-weaning of vasopressors
Safety would be assessed by monitoring for any adverse reactions due to ASV in patient 
Assessment done at 2 time points: Time of enrollment and at the time of discharge 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 

 
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