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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2010/005 |
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Date of registration:
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02/07/2010 |
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Primary sponsor: |
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Public title:
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Prevention of antivenom reactions by administering intravenous hydrocortosne 2 hours before antivenom treatment
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Scientific title:
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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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Date of first enrolment:
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1/6/2010 |
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Target sample size:
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55 patients into each arm(Total 110) |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={445739B4-7753-4F2A-A533-883C8D45D738} |
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Study type:
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Interventional |
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Study design:
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Randomized, open labeled controlled trial
Treatment Group A (Test group) -
Bolus intravenous hydrocortisone 500mg administered minimum of 2 hours before antivenom.
Treatment Group B ( Control group) - To start intravenous hydrocortisone 500 mg bolus just before antivenom infusion
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Prof SAM Kularatne
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Address:
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Department of Medicine, Faculty of Medicine, Univerisity of Peradeniya, Peradeniya
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Telephone:
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0094 773 420771 |
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Email:
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samkul@sltnet.lk |
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Affiliation:
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Professor in Medicine |
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Name:
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Prof SAM Kularatne
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Address:
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Department of Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka
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Telephone:
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0094 773 420771 |
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Email:
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samkul@sltnet.lk |
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Affiliation:
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Professor in Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Proven snake bites (with the specimen of the offending snake or evidence based diagnosis of snake bite)
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Snake bite,antivenom reactions
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Intervention(s)
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Bolus intravenous hydrocortisone 500mg administered minimum of 2 hours before antivenom
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Primary Outcome(s)
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Number of reactions
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Secondary Outcome(s)
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Severity of reactions
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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None
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