Acute organophosphate pesticide poisoning in Sri Lanka: management, complications and pharmacogenetics
| ISRCTN | ISRCTN02920054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02920054 |
| Secondary identifying numbers | GR063560 |
- Submission date
- 29/07/2002
- Registration date
- 29/07/2002
- Last edited
- 17/02/2015
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Michael Eddleston
Scientific
Scientific
Scottish Poisons Information Bureau
Royal Infirmary
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
| Phone | +44 (0)131 242 1383 |
|---|---|
| eddlestonm@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Acute organophosphate pesticide poisoning in Sri Lanka: management, complications and pharmacogenetics |
| Study objectives | We propose to carry out a randomised controlled trial of single or multi-dose activated charcoal regimens in Sri Lankan patients presenting with a history of acute poisoning. The study will look at unselected adult patients with most forms of acute poisoning. The main hypothesis is that the multi-dose activated charcoal regimen will reduce the case fatality rate from 10% to 7%, hence the first principal comparison will be multi-dose activated charcoal versus no intervention. The potential of multidose regimens to work long after ingestion - due to interruption of enterohepatic circulation and gut dialysis - means that such a regimen is more likely to work in a situation where people typically present several hours after ingestion. We suspect that a single dose will be less effective since most absorption will have taken place by the patient's presentation to hospital. Therefore, the second principal comparison will test the hypothesis that the case fatality rate in patients receiving a single dose of activated charcoal is equal to that in patients receiving multiple doses. In order to investigate whether a single dose of activated charcoal has a similar effect as giving no intervention, the third principal comparison will test the hypothesis that the case fatality rate in patients receiving a single dose of activated charcoal is equal to that in patients receiving no intervention. It is possible that both treatment regimens, if effective in reducing case fatality rates, will be more effective the earlier they are started. Therefore we will assess the trends in clinical effectiveness according to time post-ingestion to start of therapy. In order to determine whether treatment should be started irrespective of severity, we will also assess trends in case fatality rates across a gradient of severity. Admission blood samples will be retrospectively analysed to determine the identity of the poison ingested. The primary analyses will then be repeated with correction for the identity of the poison. Subgroup analyses are planned to look at the consistency of treatment effect across different types of poison i.e. dimethylated and diethylated Organophosphate (OP) pesticides, organochlorines, all pesticides, and yellow oleander. These will be carried out for the primary outcome and secondary outcomes, plus trends with time and severity. Please note that this RCT has a nested study registered under ISRCTN55264358. For more details on this nested study please visit http://www.isrctn.com/ISRCTN55264358. The overall trial end date has been extended from 31/10/2004 to 01/12/2004. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute self-poisoning in the developing world |
| Intervention | No charcoal, single 50 g dose of superactivated charcoal, multiple doses (6 x every four hour doses of superactivated charcoal). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Activated charcoal |
| Primary outcome measure | All-cause mortality at hospital discharge. |
| Secondary outcome measures | Organophosphate pesticides: 1. Percentage of patients requiring intubation 2. Period of ventilation 3. Percentage of patients developing the intermediate syndrome (cranial nerve palsies and/or proximal weakness, without distal weakness, after resolution of the cholinergic crisis) Organochlorine pesticides: Incidence of status epilepticus (continuous overt generalised seizure activity for mroe than five minutes or two generalised seizures without an intervening recovery of consciousness) Yellow oleander: 1. Cardiac dysrhythmias requiring anti-digoxin Fab (3° heart block, Mobitz type II 2° block, sinus bradycardia with heart rate less than 35 bpm, and sinus arrest or block with sinus pauses more than 3 seconds), or 2. Serum potassium greater than 6.0 |
| Overall study start date | 31/03/2002 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 4650 |
| Key inclusion criteria | All patients presenting with a history of acute self-poisoning in selected Sri Lankan hospitals |
| Key exclusion criteria | We hope to recruit all patients admitted to the medical wards with a history of acute poisoning, except for those: 1. Under the age of 14 years 2. Known to be pregnant 3. Who have ingested hydrocarbons alone or corrosives (good prognosis for former, charcoal contraindicated for latter) 4. Who require oral medication 5. Who present more than 72 hours post-ingestion 6. Patients under the age of 16 or unconscious, who are present without relatives |
| Date of first enrolment | 31/03/2002 |
| Date of final enrolment | 16/10/2004 |
Locations
Countries of recruitment
- Scotland
- Sri Lanka
- United Kingdom
Study participating centre
Scottish Poisons Information Bureau
Edinburgh
EH16 4SA
United Kingdom
EH16 4SA
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270000 |
|---|---|
| Research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol: | 11/05/2007 | Yes | No | |
| Results article | results: | 16/02/2008 | Yes | No |
