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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


  • Trial Options