| Scientific Title of Trial | Low dose versus high dose of Indian polyvalent snake antivenom in reversing neurotoxic paralysis in common krait (Bungarus cearulus) bites: an open labeled randomised controlled clinical trial in Sri Lanka | |
| Public Title of Trial (in lay language) | To find appropriate dose of antivenom(low dose/high dose regimen) for common krait bite in Sri Lanka | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Snake bite and antivenom treatment | |
| What is the research question being addressed? | To test the efficacy of low dose of antivenom compared to high dose in reversing neurotoxic respiratory paralysis in common krait bite. ? | |
| Study design | A randomized, open labeled controlled clinical trial Group A (Low dose of antivenom) or Test group - Ten vials of snake antivenom dissolved in 100 ml of normal saline and infused over 1 hour. Group B (High dose of antivenom) or Control group - Twenty vials of snake antivenom dissolved in 100 ml of normal saline and infused over 1 hour |
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| Intervention(s) planned | The enrolled patients will be treated with snake antiserum (lyophilized polyvalent enzyme-refined, manufactured in India by Vins Bioproduct Limited, Mumbai or Bharat Serums and Vaccines Limited, Ambernath) according to the following dose regimens. Group A (Low dose of antivenom) Ten vials of snake antivenom dissolved in 500 ml of normal saline and infuse over 1 hour. Group B (High dose of antivenom) Twenty vials of snake antivenom dissolved in 500 ml of normal saline and infuse over 1 hour. |
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| Inclusion criteria | 1. Patients with proven common krait bites (with an offending snake or with clear clinical evidence of common krait envenoming) 2. Older than 12 years of age 3. Presence of features of envenoming with indications for antivenom |
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| Exclusion criteria | 1. Patients who had snake anti venom treatment earlier. 2. Patients who are already having or had any neurological diseases e.g. myasthenia gravis, infective polyneuropathy, Alzheimer disease etc. 3. Patients who presented with ingestion of alcohol |
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| Target number / sample size | 1. Initialy 60 patients will be randomised to two arms of treatment 2. Depending on result of the initial phase, target sample size will be calculated for continuation study |
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| Primary outcome(s) | The duration of mechanical ventilation | |
| Primary outcome(s) - time of assessment(s) | Time in hours from the onset of intubation to extubation | |
| Secondary outcome(s) | 1. Number of patients needed mechanical ventilation 2. Time gap from antivenom treatment to intubation and ventilation 3. Time taken to complete reversal of neurotoxic signs (Ptosis, Opthalmoplegia, Neck flexon) 4. Incidence of secondary complications 5. Duration of ICU stay 6. Duration of hospital stay |
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| Secondary outcome(s) - time of assessment(s) | From the time of recruitment | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/06/2010 | |
| Anticipated end date | 31/05/2011 | |
| Recruitment status | Recruiting | |
| State of ethics review approval | Ethical approval obtained from the Research and Ethical Committee of the Faculty of Medicine, University of Peradeniya, Sri Lanka | |
| Funding source(s) | None | |
| Applicant's Email | samkul@sltnet.lk | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Prof SAM Kularatne
Professor in Medicine Department of Medicine, Faculty of Medicine,Peradeniya University, Peradeniya, SriLanka 0094 773 420771 0094 81 2388369 samkul@sltnet.lk |
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| Primary Study Sponsor/ Organization | Prof SAM Kularatne
Department of Medicine, Faculty of Medicine, Peradeniya University, Peradeniya, SriLanka 0094 773 420771 0094 81 2388369 samkul@sltnet.lk |
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| Contact Person for Public Queries | Prof SAM Kularatne Prof in Medicine Department of Medicine, Faculty of Medicine, Peradeniya University, Peradeniya 0094 773 420771 0094 81 2388369 samkul@sltnet.lk |
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| Secondary Study Sponsor(s), (if any) | None |
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