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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

Clinicaltrials.gov identifier NCT03925025

Recruitment Status Not yet recruiting

First Posted April 23, 2019

Last update posted April 23, 2019

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:Anticholinesterase Insecticide Poisoning
  • Intervention/Treatment: Drug: Magnesium Sulfate
    Drug: Nimodipine
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 3100 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
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: June 2024
Arms and interventions
Arm Intervention/treatment
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
  • 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

Contact: Michael Eddleston, ScD 01312426776 m.eddleston@ed.ac.uk

Contact: Rabbi Chowdhury, MD mastershakil@hotmail.com

Locations

Bangladesh
Chittagong Medical College
Chittagong

Sponsors and Collaborators

University of Edinburgh

Toxicology Society of Bangladesh

More Information