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

BACKGROUND: Stroke is the most common cause of death worldwide and the foremost cause of complex disability in the UK. Pneumonia causes more deaths after stroke than the neurological damage. Stroke-associated pneumonia is caused by aspiration of vomited and regurgitated gastric content. Metoclopramide, an antiemetic with both central and peripheral actions, was associated with less pneumonia and a trend to fewer deaths in our pilot study.

RESEARCH QUESTION: Does metoclopramide, given early after stroke onset and continued for 14 days, reduce mortality and prevent pneumonia? DESIGN: Two-arm parallel group, single blind randomized controlled trial with an internal pilot SETTINGS: Emergency departments and stroke units of 90 or more NHS hospitals

POPULATION: Inclusion criteria 1. Adult patients admitted to hospital with a diagnosis of acute stroke and 2. Within 9 hours of symptom onset and 3. Moderate to severe neurological impairment (NIHSS 10 or greater) and 4. Dysphagia (assessed by bedside clinical screen) Exclusion criteria 1. Probable or definite pneumonia at screening

2. Contraindications to metoclopramide 3. Pregnant or breast feeding 4. Co-morbid conditions with life expectancy