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

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ClinicalTrials.gov Identifier: NCT03925025
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Toxicology Society of Bangladesh
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anticholinesterase Insecticide Poisoning Drug: Magnesium Sulfate Drug: Nimodipine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pesticides Poisoning

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Standard therapy
Active Comparator: Magnesium sulfate
Standard therapy plus magnesium sulfate
 Drug: Magnesium Sulfate
Treatment in addition to standard therapy
Active Comparator: Nimodipine
Standard therapy plus nimodipine
 Drug: Nimodipine
Treatment in addition to standard therapy


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: through to hospital discharge, median 1 week ]
    Whether dead or alive at hospital discharge


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925025


Contacts
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Contact: Michael Eddleston, ScD 01312426776 m.eddleston@ed.ac.uk
Contact: Rabbi Chowdhury, MD mastershakil@hotmail.com

Locations
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Bangladesh
Chittagong Medical College Recruiting
Chittagong, Bangladesh
Contact: Aniruddha Ghose, MD    +8801711068841    anrdghs@yahoo.com   
Sponsors and Collaborators
University of Edinburgh
Toxicology Society of Bangladesh
More Information
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Publications:

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03925025    
Other Study ID Numbers: AC19003
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Six months after primary data analysis is published
Access Criteria: From academic group with clear analysis plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Poisoning
Chemically-Induced Disorders
Magnesium Sulfate
Nimodipine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
 Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Antihypertensive Agents
Vasodilator Agents