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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN89917816 |
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Date of registration:
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20/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clonidine in organophosphate pesticide poisoning
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Scientific title:
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Is clonidine an effective treatment in organophosphate pesticide poisoning? A phase II randomised controlled trial |
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Date of first enrolment:
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18/05/2006 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN89917816 |
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Study type:
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Interventional |
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Study design:
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Phase II multicentre dose-finding study (Treatment)
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Phase:
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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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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Andrew Hamilton
Dawson |
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Address:
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South Asian Clinical Toxicology Research Collaboration (SACTRC)
Department of Medicine
University of Peradeniya
20000
Peradeniya
Sri Lanka |
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Telephone:
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+94 (0)81 238 4556 |
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Email:
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adawson@sactrc.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients (male or female, aged 16 years or older) with symptomatic acute OP poisoning.
Exclusion criteria: 1. Patients who do not consent
2. Pregnant women
3. Patients less than 16 years of age
4. Patients who are hypotensive (blood pressure less than 90/50 mmHg) on presentation
5. Patients who have ingested other substances in addition to OP
6. Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Organophosphate poisoning
Injury, Occupational Diseases, Poisoning
Poisoning
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Intervention(s)
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Four dose levels of clonidine will be studied with the dose increased if the results in the preceding sixteen patients do not indicate any concerning dose-related adverse effects. Four patients will receive placebo and twelve patients will receive active treatment at each dose level. All patients will continue to receive standard treatment. This standard treatment is determined by the attending physician who maintains clinical responsibility for all patients. While there may be some minor variation between hospitals current care consists of patient resuscitation, gastrointestinal decontamination when indicated, atropinisation and the use of pralidoxime (typically one gram every six hours). All treatment is recorded by the research team. This intervention represents an added treatment to the existing standard of care.
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Primary Outcome(s)
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The primary outcome will be the number of patients requiring ventilation or dying in those receiving clonidine versus the placebo group.
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Secondary Outcome(s)
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Secondary outcomes will include:
1. Need for ventilation
2. Blood pressure
3. Level of consciousness
4. Duration of atropine therapy
5. Death
6. Adverse events reported by doctors will be rated by them as to the likelihood of them being due to Clonidine bolus or infusion (certain, probable, possible, unlikely)
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Source(s) of Monetary Support
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The Wellcome Trust (UK) (grant ref: 071669)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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