About this trial
Pakistan, being a developing country, is one of the regions with the most cases of organophosphate (OP) poisoning/toxicity. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. This study is being carried out with the objective of comparing the 15-day all-cause mortality rate and the total cumulative atropine requirement during hospitalization between patients receiving adjunctive magnesium sulphate with standard therapy and those receiving standard therapy alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both genders
Adult patients aged between 18 and 50 years
Confirmed clinical diagnosis of organophosphate poisoning containing insecticide, through the oral route
Adult patients, or their legally authorized representative, who will provide informed consent to participate in the study
Disqualifiers
Patients with known allergy to MgSO4
Patients with documented pre-existing renal impairment (Serum creatinine more than 1.5mg/dl)
Patients with documented pre-existing cardiac impairments (e.g., heart block)
Pregnant or lactating women
Trial design
Parallel
Treatments tested in this trial
Atropine plus pralidoxime
DrugPatients will be treated with standard atropine and pralidoxime therapy along with adjunctive MgSO4 (loading dose of 4g in 100ml N/S intravenous infusion over 30 minutes, followed by 1g/hr in 100ml N/S continuous IV infusion for 24 hours).
Atropine and pralidoxime with adjunctive MgSO4
DrugPatients will be treated with standard atropine plus pralidoxime therapy alone.
Treatment groups
Trial outcomes
Primary outcomes
Mortality
Frequency of patients will be noted who will die within 15 days to clinical stabilization.
Secondary outcomes
Intermediate Syndrome (IMS)
Frequency of patients will be noted who will develop Intermediate Syndrome (IMS) within seven days of poisoning.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammad Aamir Latif
Lead sponsor
RESnTEC, Institute of Research
Sponsor institution