Clinical trial

Outcome of OPC Poisoning Patients Between Two Treatment Groups One With Atropine Plus Pralidoxime and Other With Only Atropine

Name

59.18.1100.031.18.011.22.2268

Description

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.

Trial arms

Trial start

2023-11-01

Estimated PCD

2024-10-01

Trial end

2024-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Pralidoxime

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

Arms:

Group A

Atropine

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

Arms:

Group A, Group B

Size

Primary endpoint

Mortality rate

1 year

Eligibility criteria

Inclusion Criteria: 1. Patient having history of organophosphorus poisoning within 24 hours with features of moderate severity. (POP scale score 4-7) 2. Age above 12 years Exclusion Criteria: 1. Mixed poisons along with organophosphorus compound, 2. Patients with known case chronic diseases such as chronic lung disease, chronic kidney disease, Heart failure, malignancy, chronic liver disease

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open level, Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

Updated at

2023-11-01

1 organization

2 products

1 indication

Organization

Sir Salimullah Medical College Mitford Hospital

Product

Pralidoxime

Indication

Organophosphorus Poisoning

Product

Atropine