Home » Trials » SLCTR/2010/006
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
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SLCTR Registration Number
SLCTR/2010/006
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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
To find appropriate dose of antivenom(low dose/high dose regimen) for common krait bite in Sri Lanka
Disease or Health Condition(s) Studied
Snake bite and antivenom treatment
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
2010/EC/11 (Research and Ethical Committee of the Faculty of Medicine, University of Peradeniya)
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.
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
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.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
The duration of mechanical ventilation |
[ Time in hours from the onset of intubation to extubation ] |
Secondary outcome(s)
|
1.
|
[ From the time of recruitment ] |
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
Countries of recruitment
Sri Lanka
Anticipated start date
2010-06-01
Anticipated end date
2011-05-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2010-02-23
Approval number
2010/EC/11
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof SAM Kularatne
Professor in Medicine,
Department of Medicine, Faculty of Medicine,Peradeniya University, Peradeniya, Sri Lanka
0094 81 2388369
0094 773 420771
samkul@sltnet.lk
Contact Person for Public Queries
Prof SAM Kularatne
Professor in Medicine,
Department of Medicine, Faculty of Medicine,Peradeniya University, Peradeniya, Sri Lanka
0094 81 2388369
0094 773 420771
samkul@sltnet.lk
Primary study sponsor/organization
Prof SAM Kularatne
Department of Medicine, Faculty of Medicine,Peradeniya University, Peradeniya, Sri Lanka
0094 81 2388369
samkul@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
