Home » Trials » SLCTR/2007/005
Study on infusion rate of snake antivenom therapy
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SLCTR Registration Number
SLCTR/2007/005
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Study on infusion rate of snake antivenom therapy
Public Title of Trial
Study on infusion rate of snake antivenom therapy
Disease or Health Condition(s) Studied
Snakebites requiring antivenom administration
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/04/044 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Does infusion rate determine the adverse effects of infusion?
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
Patients will be randomly allocated to two groups and one will receive antivenom dose over 20 minutes while the others will receive the same dose over 2 hours.
Inclusion criteria
Patients with a possible clinical diagnosis of a snakebite
Exclusion criteria
Primary outcome(s)
|
1.
Proportion with severe systemic allergic reactions within 4 hours of commencement of antivenom |
[ within 4 hours of commencement ] |
Secondary outcome(s)
|
1.
|
[] |
Target number/sample size
206
Countries of recruitment
Sri Lanka
Anticipated start date
2007-01-01
Anticipated end date
2007-12-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
IRQUE project C1A2 MBBS SPQEF Grant
Regulatory approvals
Status
Approved
Date of Approval
2004-07-15
Approval number
EC/04/044
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Ariaranee Gnanathasan
Senior Lecturer
Department of Clinical Medicine,
Faculty of Medicine, University of Colombo
4(0)112689188
+94(0)112689188
ariaranee2000@yahoo.com
Contact Person for Public Queries
Dr. R.M.S.H. Karunatilake
Consultant Physician
General Hospital, Chilaw
+ 94(0)714348453
sunyalharindra@yahoo.com
Primary study sponsor/organization
IRQUE Project
Local Technical Secretariat,
University of Colombo,
P.O. box 1490,
Munidasa Kumaratunga Mawatha,Colombo 3
+ 94(0)112595953, + 94(0)112581835 ext 191
+94(0)112595953
office@lts.cmb.ac.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
