Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime

NCT06111352 | Completed Phase 2

• 1 other identifier: 59.18.1100.031.18.011.22.2268
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This open level randomized controlled trial will be conducted in the department of medicine at Sir Salimullah Medical College and Mitford Hospital. Clinical severity will be assessed by the POP (Peradeniya Organophosphorus Poisoning) scale of admitted patients having a history of organophosphorus poisoning within 24 hours with clinical features and physical evidence of poisoning consumed. Only moderate severity (POP Scale score 4-7) of OPC (Organophosphorus compound) patients will be included in this study. Then one group of patients will be treated with atropine and pralidoxime and another group will be treated with atropine. The outcome will be noted as clinical improvement or recovery. hospital stay, requirement of ICU, death.

Conditions

Organophosphorus Poisoning

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  1 year

Secondary Outcomes (1)

• Proportion of patients who required intubation

  1 year

Study Arms (2)

Group A

EXPERIMENTAL

Patients will be treated with Atropine plus pralidoxime Pralidoxime: Dosage:1gram; Dosage form: Intravenous infusion; Frequency: 8 hourly Atropine:

Drug: Pralidoxime; Drug: Atropine

Group B

OTHER

Patients will be treated with only atropine

Drug: Atropine

Interventions

Pralidoxime DRUG

Inj. Pralidoxime 1 gm I/V will be given as first dose over 10-20 minutes. If no improvement of muscle weakness, then repeat the dose after one hour. Then 1 gram of Inj. Pralidoxime will be given at an 8-hour interval

Group A

Atropine DRUG

Inj. Atropine (3 ampule) will be given in intravenous route as a first dose, rapidly. Then the dose will be doubled from the previous dose in every 5 minutes interval until the signs of atropinisation appeared. Then infusion of 10% of the total bolus dose (the dose that was given until the signs of atropinisation appeared) per hour, will be given with intravenous Normal saline/ 5% DNS(Dextrose and Sodium chloride) as a maintenance dose. The dose will be reduced for adjustment, based on clinical features/improvement

Group A; Group B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having history of organophosphorus poisoning within 24 hours with features of moderate severity. (POP scale score 4-7)
• Age above 12 years

You may not qualify if:

• Mixed poisons along with organophosphorus compound,
• Patients with known case chronic diseases such as chronic lung disease, chronic kidney disease, Heart failure, malignancy, chronic liver disease

Sponsors & Collaborators

• Sir Salimullah Medical College Mitford Hospital: lead

Study Sites (1)

Sir Salimullah Medical College Mitford Hospital

Dhaka, 1100, Bangladesh

Location

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

pralidoxime; Atropine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, Medical officer, Sir salimullah Medical College Mitford Hospital, Dhaka, Bangladesh

Model Details: Open level, Randomized controlled trial

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: November 1, 2023
• Study Start: June 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)