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

NCT05927259 | Completed Early Phase 1 DMC

• 1 other identifier: R214/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Conditions

Acute Organophosphorus Poisoned Patients

Outcome Measures

Primary Outcomes (1)

• mortality

  72 hours

Study Arms (2)

study group

ACTIVE COMPARATOR

Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)

Drug: n acetyl cysteine; Drug: standard treatment

control group

OTHER

Patients who will receive conventional treatment only

Drug: standard treatment

Interventions

n acetyl cysteine DRUG

A patients received NAC 140 mg/Kg IV infusion (as a loading dose), then 70 mg/KgIV infusion every 4 hours up to 17 doses

study group

standard treatment DRUG

stabilization and antidotes

Also known as: atropine and oximes

control group; study group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (3)

faculty of medicine Ain shams university

Cairo, None Selected, 11566, Egypt

Location

Faculty of Medicine

Cairo, None Selected, 11566, Egypt

Location

Poison Control Center Ain Shams University Hospitals

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Acetylcysteine; Atropine; Oximes

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Hydroxylamines; Amines

Study Officials

• Sarah S Mohammed

  faculty of medicine ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of clinical toxicology

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)