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出境医 / 临床实验 / Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning (CCBOC)

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

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE December 11, 2020
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		Mortality [ Time Frame: through to hospital discharge, median 1 week ]
Whether dead or alive at hospital discharge
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning
Official Title  ICMJE Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anticholinesterase Insecticide Poisoning
Intervention  ICMJE
  • Drug: Magnesium Sulfate
    Treatment in addition to standard therapy
  • Drug: Nimodipine
    Treatment in addition to standard therapy
Study Arms  ICMJE
  • No Intervention: Control
    Standard therapy
  • Active Comparator: Magnesium sulfate
    Standard therapy plus magnesium sulfate
    Intervention: Drug: Magnesium Sulfate
  • Active Comparator: Nimodipine
    Standard therapy plus nimodipine
    Intervention: Drug: Nimodipine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2021) 		3243
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		3100
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Eddleston, ScD 01312426776 m.eddleston@ed.ac.uk
Contact: Rabbi Chowdhury, MD mastershakil@hotmail.com
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925025
Other Study ID Numbers  ICMJE AC19003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Six months after primary data analysis is published
Access Criteria: From academic group with clear analysis plan
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Toxicology Society of Bangladesh
Investigators  ICMJE Not Provided
PRS Account University of Edinburgh
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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