Magnesium Sulphate With Atropine and Pralidoxime vs Standard Therapy Alone in Acute Organophosphate Poisoning

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMuhammad Aamir Latif

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Atropine plus pralidoxime

    Drug

    Patients 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

    Drug

    Patients will be treated with standard atropine plus pralidoxime therapy alone.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Atropine plus pralidoxime with MgSO4-GroupExperimental treatment 2 interventions
Group B: Atropine plus pralidoxime-GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Frequency of patients will be noted who will die within 15 days to clinical stabilization.

Time frame
15 days after hospital admission

Secondary outcomes

1

Intermediate Syndrome (IMS)

Frequency of patients will be noted who will develop Intermediate Syndrome (IMS) within seven days of poisoning.

Time frame
7 days after poisoning

Other outcomes

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