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

18 May 2007

The date of last modification

Jan 30, 2019


View original TRDS


Trial Status



Application Summary


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)


Trial Details


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

  • Under 14 years of age * Pregnant ladies * Previous administration of antivenom * Refusal of consent


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)

    • Proportion with elevated mast cell tryptase * Proportion with elevated antivenom specific IgE * Hospital length of stay * Proportion with mild allergic reactions * Proportion with delayed administration of -further antivenom therapy * Proportion developing serum sickness
    []

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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