Effectiveness of Calcium Channel Blockade for OP and Carb... | NCT03925025

Studies
Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

NCT03925025

Sponsor

University of Edinburgh

Status

Completed

Last Update Posted

Oct 1, 2025Actual

Enrollment

1,728Actual

Phase

Phase 3

Conditions

Anticholinesterase Insecticide Poisoning
Pesticide Poisoning

Interventions

Magnesium Sulfate
Nimodipine

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2020Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Apr 30, 2025Actual

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Apr 22, 2019

First Posted Date

Apr 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2025

Last Update Posted Date

Oct 1, 2025Actual

Name	Class
Toxicology Society of Bangladesh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,728Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug	Treatment in addition to standard therapy	Magnesium sulfate

Measure	Description	Time Frame
Mortality	Whether dead or alive at hospital discharge	through to hospital discharge, median 1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dr Fazle Rabbi Chowdhury, MD	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rajshahi Medical College Hospital		Rajshahi	Rajshahi Division	6100	Bangladesh
Shaheed Ziaur Rahman Medical College

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29557685	Background	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.

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids