The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus Pesticide Poisoning

Early Phase 1

Completed

• Conditions: Acute Organophosphorus Poisoned Patients
• Interventions: Drug: standard treatment; Drug: n acetyl cysteine

• Registration Number: NCT05927259
• Lead Sponsor: Ain Shams University

Brief Summary

All patients admitted in the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure , clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.

Group 1 -. Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) and Group 2 - Patients who will receive conventional treatment only

Detailed Description

40 patients with acute organophosphorus poisoning will be randomly assigned as control groups and study group in a 1:1 ratio ( 20 patients in each group). The diagnosis of acute organophosphorus intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.

Group 1 - Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) Group 2 - Patients who will receive conventional treatment only

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-05-01
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All patients (above 16 years) admitted to the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. -

Exclusion Criteria

• Based on the possibility of alteration in measured parameters and/or biomarkers, patients below 16 years or above 60 years Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	standard treatment	Patients who will receive conventional treatment only
study group	standard treatment	Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)
study group	n acetyl cysteine	Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)

Primary Outcome Measures

Name	Time	Method
mortality	72 hours

Trial Locations

Locations (3)

Faculty of Medicine; 🇪🇬 Cairo, None Selected, Egypt

faculty of medicine Ain shams university; 🇪🇬 Cairo, None Selected, Egypt

Poison Control Center Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt