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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Acute Organophosphorus Poisoned Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type ACTIVE_COMPARATOR

n acetyl cysteine

Intervention Type 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

standard treatment

Intervention Type DRUG

stabilization and antidotes

control group

Patients who will receive conventional treatment only

Group Type OTHER

standard treatment

Intervention Type DRUG

stabilization and antidotes

Interventions

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n acetyl cysteine

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

Intervention Type DRUG

standard treatment

stabilization and antidotes

Intervention Type DRUG

Other Intervention Names

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atropine and oximes

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No