Clonidine in organophosphate pesticide poisoning
| ISRCTN | ISRCTN89917816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89917816 |
| Protocol serial number | 071669 |
| Sponsor | South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka) |
| Funder | The Wellcome Trust (UK) (grant ref: 071669) |
- Submission date
- 20/07/2007
- Registration date
- 20/07/2007
- Last edited
- 26/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Hamilton Dawson
Scientific
Scientific
South Asian Clinical Toxicology Research Collaboration (SACTRC)
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
| Phone | +94 (0)81 238 4556 |
|---|---|
| adawson@sactrc.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II multicentre dose-finding study |
| Secondary study design | Multi-centre |
| Scientific title | Is clonidine an effective treatment in organophosphate pesticide poisoning? A phase II randomised controlled trial |
| Study acronym | SACTRC |
| Study objectives | What is the safe and effective clonidine regimen in Organophosphate (OP) poisoning that will: 1. Reduce mortality and/or the need for ventilation 2. Provide moderate sedation 3. Not cause symptomatic adverse effects on blood pressure |
| Ethics approval(s) | Sri Lankan Medical Association Ethics Review Board approved on 5th August 2005 (ref: ERC/05-008) |
| Health condition(s) or problem(s) studied | Organophosphate poisoning |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Clonidine |
| Primary outcome measure(s) | The primary outcome will be the number of patients requiring ventilation or dying in those receiving clonidine versus the placebo group. |
| Key secondary outcome measure(s) | 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) |
| Completion date | 03/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | Patients (male or female, aged 16 years or older) with symptomatic acute OP poisoning. |
| Key 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) |
| Date of first enrolment | 18/05/2006 |
| Date of final enrolment | 03/03/2008 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centre
South Asian Clinical Toxicology Research Collaboration (SACTRC)
Peradeniya
20000
Sri Lanka
20000
Sri Lanka
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
