Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning (CCBOC)

University of Edinburgh

Status and phase: Completed; Phase 3

Conditions: Pesticide Poisoning; Anticholinesterase Insecticide Poisoning

Treatments: Drug: Magnesium Sulfate; Drug: Nimodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT03925025

AC19003

Details and patient eligibility

About

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.

Enrollment: 1,728 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,728 participants in 3 patient groups

Control

No Intervention group

Description:

Standard therapy

Magnesium sulfate

Active Comparator group

Description:

Standard therapy plus magnesium sulfate

Treatment:

Drug: Magnesium Sulfate

Nimodipine

Active Comparator group

Description:

Standard therapy plus nimodipine

Treatment:

Drug: Nimodipine