ISRCTN40512746进行中（未招募）3 期
The Metoclopramide for Avoiding Pneumonia after Stroke (MAPS-2) trial: a single-blind, randomized controlled trial of metoclopramide for the prevention of pneumonia in patients with dysphagia after an acute stroke
niversity of Nottingham0 个研究点目标入组 1,200 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 04/04/2024:
- •1. Adults (18 years and over) with a clinical diagnosis of acute stroke (WHO definition excluding duration)
- •2. Within 24 hours of symptom onset (in wake-up stroke the onset is defined as the time the patient awoke or was found unless this is more than 12 h from last known well)
- •3. One of the two below criteria:
- •3a. Moderate to severe neurological impairment (NIH Stroke Scale/Score (NIHSS) =10) OR
- •3b. Dysphagia and NIHSS =6, unable to take normal unmodified oral diet or fluids because:
- •i) Too drowsy to be assessed formally or
- •ii) Failed bedside assessment of swallowing
- •Previous inclusion criteria as of 14/03/2023:
- •1. Adults (18 years and over) with a clinical diagnosis of acute stroke (WHO definition excluding duration)
- •2. Within 24 hours of symptom onset (in wake-up stroke the onset is defined as the time the patient awoke or was found unless this is more than 12 h from last known well)
- •3. Moderate to severe neurological impairment (NIH Stroke Scale/Score (NIHSS) =10)
- •4. Unable to take normal unmodified oral diet or fluids because:
- •4.1. Too drowsy to be assessed formally or
- •4.2. Failed bedside assessment of swallowing
- •Previous inclusion criteria:
- •1. Adults (18 years and over) with a clinical diagnosis of acute stroke (WHO definition excluding duration)
- •2. Within 9 hours of symptom onset (in wake-up stroke the onset is defined as the time the patient awoke or was found unless this is more than 12 h from last known well)
- •3. Moderate to severe neurological impairment (NIH Stroke Scale/Score (NIHSS) =10)
- •4. Unable to take normal unmodified oral diet or fluids because:
- •4.1. Too drowsy to be assessed formally or
- •4.2. Failed bedside assessment of swallowing
排除标准
- •1. Definite or probable pneumonia (abnormal chest X-ray suggestive of pneumonia or focal chest signs with fever =38°C, or receiving antibiotic treatment at time of presentation)
- •2. Contraindications to metoclopramide (hypersensitivity to metoclopramide, epilepsy, gastrointestinal obstruction, perforation, or haemorrhage, gastrointestinal surgery within the last week, Parkinson’s disease, treatment with levodopa or dopaminergic agonists, phaeochromocytoma or neuroleptic malignant syndrome or tardive dyskinesia or methaemoglobinaemia or NADH cytochrome –b5 deficiency)
- •3. Clinical indication for regular antiemetic treatment
- •4. Known cirrhosis of the liver
- •5. Known severe renal dysfunction (eGFR <30 ml/hour)
- •6. Pregnant or breastfeeding
- •7. Moribund (expected to die within the next 48 hours)
- •8. Co-morbid conditions with life expectancy <3 months
- •9. Inability to gain consent (patient or legal representative) or consent declined
研究者
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