Contact information
Type
Scientific
Contact name
Dr Aishath Aroona
ORCID ID
Contact details
SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
+94 (0)81 238 4556
aroona@sactrc.org
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
071669
Study information
Scientific title
Is magnesium an effective treatment for organophosphate poisoning?
Acronym
Study hypothesis
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
Study design
Multicentre double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Magnesium
Primary outcome measure
The primary outcome will be the number of patients dying in those receiving magnesium versus those receiving placebo.
Secondary outcome measures
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).
Overall study start date
30/08/2006
Overall study end date
03/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with symptomatic acute OP
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
300
Participant 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)
Recruitment start date
30/08/2006
Recruitment end date
03/03/2009
Locations
Countries of recruitment
Sri Lanka
Study participating centre
SACTRC
Peradeniya
20000
Sri Lanka
Sponsor information
Organisation
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Sponsor details
Department of Medicine
University of Peradeniya
Perideniya
20000
Sri Lanka
+94 (0)81 238 4556
adawson@sactrc.org
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|