NCT03925025已完成3 期
Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,728
- 试验地点
- 7
- 主要终点
- Mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Magnesium sulfate
Active Comparator
Standard therapy plus magnesium sulfate
干预措施: Magnesium Sulfate (Drug)
Nimodipine
Active Comparator
Standard therapy plus nimodipine
干预措施: Nimodipine (Drug)
结局指标
主要结局
Mortality
时间窗: through to hospital discharge, median 1 week
Whether dead or alive at hospital discharge
次要结局
未报告次要终点
研究者
研究点 (7)
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