Organophosphate Poisoning
Conditions
Brief summary
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.
Detailed description
The current standard therapy in OP is lacking in managing the Intermediate Syndrome (IMS) and the delayed complications. This deficiency underscores the need for carrying out research to test the efficacy of adjunct compounds in the better management of the toxicity of this deadly substance. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. In a setting where economic instability and a compromised health system put an uneven burden on the shoulders of the patient, introducing a regimen that could possibly reduce the hospital stay and prevent the use of ventilators can be very healthy for the pockets of the government bodies as well as the patient's attendants. Assessing atropine consumption, need for mechanical ventilation, incidence of respiratory failure due to IMS, length of hospital admission, and mortality in the treatment would enable clinicians to recognize whether the adjunctive treatment is efficacious in achieving reasonable outcomes or not.
Interventions
DRUGAtropine plus pralidoxime
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).
DRUGAtropine and pralidoxime with adjunctive MgSO4
Patients will be treated with standard atropine plus pralidoxime therapy alone.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Confirmed intake of any other drug or poison * Patients who will be declared dead on arrival or those who expired within 2 hours of presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 15 days after hospital admission | Frequency of patients will be noted who will die within 15 days to clinical stabilization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intermediate Syndrome (IMS) | 7 days after poisoning | Frequency of patients will be noted who will develop Intermediate Syndrome (IMS) within seven days of poisoning. |
Countries
Pakistan
Contacts
CONTACTSana Usman
CONTACTArif Mahmood, FCPS
PRINCIPAL_INVESTIGATORSana Usman
Nishtar Hospital Multan, Pakistan
STUDY_DIRECTORArif Mahmood, FCPS
Nishtar Hospital Multan, Pakistan
Outcome results
None listed