Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

NCT03925025 | Completed Phase 3 DMC

• 1 other identifier: AC19003
• Study Type: interventional
• Target: 1,728
• Locations: 1 country
• Sites: 7

Brief Summary

This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.

Conditions

Anticholinesterase Insecticide Poisoning; Pesticide Poisoning

Outcome Measures

Primary Outcomes (1)

• Mortality

  Whether dead or alive at hospital discharge

  through to hospital discharge, median 1 week

Study Arms (3)

Control

NO INTERVENTION

Standard therapy

Magnesium sulfate

ACTIVE COMPARATOR

Standard therapy plus magnesium sulfate

Drug: Magnesium Sulfate

Nimodipine

ACTIVE COMPARATOR

Standard therapy plus nimodipine

Drug: Nimodipine

Interventions

Magnesium Sulfate DRUG

Treatment in addition to standard therapy

Magnesium sulfate

Nimodipine DRUG

Treatment in addition to standard therapy

Nimodipine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine.
• Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp.
• Patients who ingest combination products containing OP or carbamate insecticides will also be included.
• Inhibited blood cholinesterase activity as shown by routine clinical bedside test

You may not qualify if:

• Children aged \<16 years.
• Patients who do not require atropine and have not had it prior to presentation during this episode.
• Normal blood cholinesterase activity
• Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response)
• Known occupational and homicidal poisoning
• Past medical history of severely impaired renal function
• Hypersensitivity to magnesium and its salts
• Patients who have had a myocardial infarction or unstable angina in the last month
• Patients with traumatic subarachnoid haemorrhage
• Lack of informed consent (unaccompanied unconscious patients and others)

Sponsors & Collaborators

• University of Edinburgh: lead
• Toxicology Society of Bangladesh: collaborator

Study Sites (7)

Rajshahi Medical College Hospital

Rajshahi, Rajshahi Division, 6100, Bangladesh

Location

Shaheed Ziaur Rahman Medical College

Bogra, Silimpur, 5800, Bangladesh

Location

Chattogram Medical College Hospital

Chittagong, 4203, Bangladesh

Location

Jashore Medical College Hospital

Jessore, Bangladesh

Location

Khulna Medical College Hospital

Khulna, Bangladesh

Location

Rangpur Medical College Hospital

Rangpur City, Bangladesh

Location

Sylhet MAG Osmani Medical College Hospital

Sylhet, Bangladesh

Location

Related Publications (1)

• Brvar M, Chan MY, Dawson AH, Ribchester RR, Eddleston M. Magnesium sulfate and calcium channel blocking drugs as antidotes for acute organophosphorus insecticide poisoning - a systematic review and meta-analysis. Clin Toxicol (Phila). 2018 Aug;56(8):725-736. doi: 10.1080/15563650.2018.1446532. Epub 2018 Mar 20.

  PMID: 29557685 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate; Nimodipine

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids

Study Officials

• Dr Fazle Rabbi Chowdhury, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Study Start: June 11, 2020
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months after primary data analysis is published
• Access Criteria: From academic group with clear analysis plan

Locations

BA (7)