Home » Trials » SLCTR/2010/005


Efficacy of intravenous hydrocortisone administered 2 hours prior to antivenom as prophylaxis against adverse reactions to snake antivenom in Sri Lanka

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SLCTR Registration Number

SLCTR/2010/005


Date of Registration

02 Jul 2010

The date of last modification

Mar 03, 2019


Trial Status



Application Summary


Scientific Title of Trial

Efficacy of intravenous hydrocortisone administered 2 hours prior to antivenom as prophylaxis against adverse reactions to snake antivenom in Sri Lanka


Public Title of Trial

Prevention of antivenom reactions by administering intravenous hydrocortosne 2 hours before antivenom treatment


Disease or Health Condition(s) Studied

Snake bite,antivenom reactions


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

2009/EC/74 (Research and Ethical Committee of the Faculty of Medicine, University of Peradeniya)


Trial Details


What is the research question being addressed?

To evaluate the efficacy of intravenous hydrocortisone administered 2 hours prior to commencement of antivenom as a prophylaxis against adverse reactions of polyvalent snake antivenom ?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment

Single


Purpose

Prevention


Study Phase

Not Available


Intervention(s) planned

Bolus intravenous hydrocortisone 500mg administered minimum of 2 hours before antivenom


Inclusion criteria

  1. Proven snake bites (with the specimen of the offending snake or evidence based diagnosis of snake bite)
  2. Antivenom is indicated.
  3. Above 12 years of age.

Exclusion criteria

  1. Patients who had already received hydrocortisone, antihistamines or adrenaline as prophylaxis, snake antivenom treatment earlier.
  2. Patients who had previous history of eczema, urticaria, drug or food allergies.
  3. Patients who admit with well established envenoming signs


Primary outcome(s)

1.

Number of reactions

[

From the time of antivenom administration

]

Secondary outcome(s)

1.

Severity of reactions

[

From the time of antivenom administration

]

Target number/sample size

55 patients into each arm(Total 110)


Countries of recruitment

Sri Lanka


Anticipated start date

2010-06-06


Anticipated end date

2011-01-31


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2010-03-23


Approval number

2009/EC/74


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 & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof SAM Kularatne
Professor in Medicine
Department of Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka
0094 773 420771
00094 81 2388369

samkul@sltnet.lk

Contact Person for Public Queries

Prof SAM Kularatne
Professor in Medicine
Department of Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka
0094 773 420771
00094 81 2388369

samkul@sltnet.lk


Primary study sponsor/organization

Prof SAM Kularatne
Professor in Medicine
Department of Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka
0094 773 420771,

samkul@sltnet.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