Prevention of pneumonia caused by dysphagia after an acute stroke Digestive System
Conditions
Interventions
Participants will be individually randomized 1:1 via a web-based interface to metoclopramide or sham control by minimization using NIH Stroke Scale/Score (NIHSS), age, modified Rankin score (mRS), tim
their quality of life
whether they still have problems swallowing
if they are still in hospital or, if not, where they are living. A health economic analysis will be done to look at potential cost savings as a result of shorter hospital stays and fewer re-admissions
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality by 6 months (time-to-event), ascertained by contacting the general practitioner in the first instance. Missing data will be completed with the team who recruited the patient and via linkage with Hospital Episode Statistics and The Office of National Statistics. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Development of pneumonia, diagnosed by the clinical care team and retrieved from medical notes at 14 days 2. Development of pneumonia specifically attributed to the stroke event (diagnosis based on standard criteria determined by the Stroke Consensus group published in 2015) retrieved from daily clinical log at 14 days 3. Antibiotic treatment, measured as the number of days on treatment, retrieved from medical notes and drug charts at 14 days 4. Difficulty in swallowing measured using the standard Dysphagia Severity Rating Scale Score (DSRS) at 14 days and 6 months 5. Severity of stroke assessed by the NIH Stroke Score at baseline and 14 days 6. Quality of life assessed by the EuroQol EQ-5D questionnaire at 14 days and 6 months 7. Degree of disability evaluated by an ordinal shift in the modified Rankin score (mRS) at 6 months 8. Vulnerability to poor health outcomes assessed by Clinical Frailty Scale index at 6 months 9. Home time, defined as the number of days spent at home rather than hospitalised, at 6 months | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactChristine Roffe
Outcome results
None listed