Clonidine in organophosphate pesticide poisoning
| ISRCTN | ISRCTN89917816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89917816 |
| Secondary identifying numbers | 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
| Study design | Phase II multicentre dose-finding study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Clonidine |
| Primary outcome measure | The primary outcome will be the number of patients requiring ventilation or dying in those receiving clonidine versus the placebo group. |
| Secondary outcome measures | 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) |
| Overall study start date | 18/05/2006 |
| Completion date | 03/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 64 (recruitment ends on 03/03/2008) |
| 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
Sponsor information
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Research organisation
Research organisation
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
| Phone | +94 (0)81 238 4556 |
|---|---|
| adawson@sactrc.org | |
| Website | http://www.sactrc.org |
"ROR" |
https://ror.org/04z435g27 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 071669)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
