Daboia russelii and Echis carinatus snakebite
Conditions
Interventions
Phase III RCT (patients with Daboia russelii or Echis carinatus bites)
The study will be conducted in medical wards of collaborating hospitals. Participants meeting inclusion/exclusion criteria will
Sponsors
South Asian Clinical Toxicology Research Collaboration
Eligibility
Inclusion criteria
Inclusion criteria: 1. History of snake bite with Daboia russelii or Echis carinatus (by clinical manifestations/visual identification of the snake where possible) 2. Evidence of systemic envenomation based on Ministry of Health/Sri Lanka Medical Association guidelines.
Exclusion criteria
Exclusion criteria: 1. <14 years of age 2. Pregnancy 3. Already received antivenom, fresh frozen plasma (FFP), or pre-medication such as adrenaline, hydrocortisone or promethazine at the primary hospital 4. History of allergy to antivenom 5. Inability to give direct or proxy consent (unconscious and unaccompanied by a relative) 6. Presentation more than 8 hours after snake bite.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Early anaphylactic-like reactions (up to 04 hrs) i. Mild: pruritus and/or urticarial only ii. Severe: Gastrointestinal symptoms (vomiting, diarrhoea, colicky abdominal pain) iii. Bronchospasm, or fall in systolic blood pressure below 90 mmHg. 2. Early Pyrogenic reactions (upto 4 hours): increase oral temperature 38°C or above with or without rigors 3. Late serum sickness type antivenom reactions (2 weeks later): urticarial, pruritus, arthralgia, fever [1. Every 15 minutes during antivenom administration (for upto 1 hour) and every 30 minutes thereafter up to 4 hours. 2. Every 15 minutes during antivenom administration (for upto 1 hour) and every 30 minutes thereafter up to 4 hours. 3. 2 weeks after discharge from hospital ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood coagulability [assessed by prothrombin time (PT) and International Normalized ratio (INR) and Whole Blood Clotting Test 20 min (WBCT20). 2. Free venom concentration in blood serum 3. Clotting factors concentrations (Activated partial thromboplastin time [aPTT] fibrinogen, X, V, VII, VIII, D-dimer) 4. Hematological parameters: Hemoglobin concentration, haematocrit, white cell count, platelet count 5. Urinary markers of acute kidney injury (NGAL, ?2-microglobulin, KIM) 6. Myotoxicity as assessed by creatine kinase (CK) 7. Renal toxicity as assessed by NGAL, 2-microglobulin, KIM and serum creatinine 8. Duration of hospital stay 9. Duration of mechanical ventilation. 10. Requirements for repeated dosing of antivenom 11. Requirements for fresh frozen plasma (FFP) 12. Requirements for packed red cells or platelets [Secondary outcomes 1-7 will be measured at 6, 12, 18, 24 and 48 hours after the initial dose of antivenom Secondary outcome 8 will be measured as the time of initiation of AVS to time of discharge from the hospital Secondary outcome 9 measured from the time of initiation of mechanical ventilation until extubation Secondary outcomes 10-12 will be measured at 6 hours post treatment ] | — |
Countries
Sri Lanka
Contacts
Public ContactProfessor Indika Bandara Gawarammana
Professor in Medicine
Outcome results
None listed