Is magnesium an effective treatment for organophosphate poisoning?
| ISRCTN | ISRCTN50739829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50739829 |
| Protocol serial number | 071669 |
| Sponsor | South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka) |
| Funder | Wellcome Trust |
- Submission date
- 31/07/2006
- Registration date
- 31/07/2006
- Last edited
- 05/02/2015
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Aishath Aroona
Scientific
Scientific
SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
| Phone | +94 (0)81 238 4556 |
|---|---|
| aroona@sactrc.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Is magnesium an effective treatment for organophosphate poisoning? |
| Study objectives | Is magnesium effective in reducing mortality from acute Organophosphate Poisoning (OP)? Due to a delay to the beginning of the trial, the overall trial start date is now 03/03/2007. The overall trial end date was also therefore changed to 03/03/2009. |
| Ethics approval(s) | 1. Sri Lankan Medical Association Ethical Review Committee (Approval ERC/05-005), 05/08/2005. 2. Australian National University Human Ethics Research Committee (Approval 2005/195), 29/10/2005 |
| Health condition(s) or problem(s) studied | Organophosphate poisoning |
| Intervention | We plan to conduct a double-blind randomised controlled trial of the effectiveness of early magnesium treatment in preventing death. Patients will be randomised to magnesium sulphate or a placebo in a 2:1 ratio. (i.e 200 patients will receive magnesium and 100 patients will receive placebo). 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 | Not Specified |
| Drug / device / biological / vaccine name(s) | Magnesium |
| Primary outcome measure(s) |
The primary outcome will be the number of patients dying in those receiving magnesium versus those receiving placebo. |
| Key secondary outcome measure(s) |
Secondary outcomes will include need for ventilation, blood pressure, level of consciousness and duration of atropine therapy. Adverse events reported by doctors will be rated by them as to the likelihood of them being due to magnesium infusion (certain, probable, possible, unlikely). |
| Completion date | 03/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | Patients with symptomatic acute OP |
| 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 and not responding to intravenous (iv) fluids and atropine 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 | 30/08/2006 |
| Date of final enrolment | 03/03/2009 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centre
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 |
