Snakebite envenomation
Conditions
Interventions
The study will be conducted in Medical wards of 3 selected centers in Sri Lanka- TH Anuradhapura, TH- Rathnapura, BH- Kilinochch
At first, about 20 patients with snakebite eligible to receive ASV will
Sponsors
George Steuart & Company
Eligibility
Inclusion criteria
Inclusion criteria: • Any patient of either sex, • Age between 18 and 60 years • Patients reporting with the history of confirmed snakebite, • SL-ASV will be administered only for systemic envenoming effects except local manifestations of confirmed cobra bites. The systemic envenoming effects are as follows: 1. Neurotoxic envenomation- Patients with ptosis, external ophthalmoplegia and respiratory failure 2. Haemotoxic envenomation- Patient presenting with bleeding manifestations with laboratory confirmation of coagulopathy such as WBCT >20 minutes (Whole Blood Clotting Test), elevated PT/INR and APTT. Local effects are as follows: 1. Patients presenting with local pain, swelling and necrosis following only for confirmed cobra bites. • Following are the criteria/indications for giving SL-ASV for hump- nosed viper bites 1 Patients with positive WBCT20 and or elevated PT/INR (VICC) . 2. Patients with oliguria/anuria (UOP 27 µmol/L relative to a known base line value within 48 hrs/ or clinical diagnosis) [acute kidney injury]
Exclusion criteria
Exclusion criteria: • Pre-existing renal disease, uncontrolled chronic obstructive airway disease, congestive heart failure and previous myocardial infarction • Patients taking diuretics, anticoagulants and antiplatelet drugs • Pregnant mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in clinical criteria 1. Improvement of bleeding manifestations 2. Improvement of neurological manifestations (neck muscle power/improvement of ophthalmoplegia/ptosis) 3. Improvement of renal manifestations (urine output) 4. Improvement of local reaction [Post AVS at 1 hour, 6 hours, 24 hours, and 48 hours.] Improvement in laboratory criteria: 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) 3. Improvement of renal abnormalities (Serum creatinine) 4. Improvement of inflammatory response (white cell count/C-reactive protein) [Post AVS at 1 hour, 6 hours, 24 hours, and 48 hours.] Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions. [Post AVS at 1 hour, 6 hours, 24 hours, and 48 hours] Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein). [ ] Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions. [ ] Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein). [ ] Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions. [ ] Improvement in labora | — |
Secondary
| Measure | Time frame |
|---|---|
| Total dose of SL-ASV used to achieve clinical improvement [] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] Total time required for clinical recovery and discontinuation of SL-ASV [ ] Total duration of hospital stay. [ ] Number of cases suffering complications of snakebite [ ] | — |
Countries
Sri Lanka
Contacts
Public ContactS.A.M.Kularatne
Senior Professor of Medicine
Outcome results
None listed