Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
This study will test two ways of preventing pneumonia in stroke patients who are being fed through a tube. The first method will be to prevent patients from vomiting using a drug called metoclopramide
Sponsors
University Hospitals North Midlands (UHNM) NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with a clinical diagnosis of acute stroke 2. Within 9 hours of stroke onset 3. Moderate to severe neurological impairment with and NIHSS score of 10 or above 4. Unable to take a normal oral diet or fluids because too drowsy to be assessed formally or failed bedside assessment of swallowing
Exclusion criteria
Exclusion criteria: 1. Evidence of vomiting since stroke onset 2. Pre-existing swallowing problem 3. Known oesphageal pathology that might interfere with placement of a nasogastric tube 4. Probable or definite pneumonia 5. Contraindications to metroclopramide, epilepsy, gastrointestinal obstruction, perforation, or haemorrhage, gastrointestinal surgery within the last week, Parkinson's disease, treatment with levodopa or dopaminergic agonists, phaeochromocytoma or neuroleptic maligant syndrome or tardive dyskinesia or methaemoglobinaemia or NADH cytochrome 6. Patients with severe liver disease or kidney disease 7. Known allergy to colistin 8. Pregnant or breastfeeding 9. Other co-morbid conditions with a life expectancy of less than 3 months at the discretion of the clinical treating team 10. Inability to gain consent from the patient or a legal representative or refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality up to the end of the study (90 days). The patients' vital status will be assessed during months 26-32, giving a maximum follow-up of 24 months for participants recruited in month 1 and 3 months for participants recruited at the end of the study. This will be done by phone call to the GP, and, where necessary, the participant or the contacts they provide. Missing data will be ascertained with the team who recruited the patient, and via linkage with Hospital Episode Statistics, Office of National Statistics, and Sentinel Stroke National Audit datasets. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pneumonia within 14 days. This is taken from data collected on the daily log. The study team will look at the clinical diagnosis and indication for antibiotics and CDC and modified MANN criteria. 2. Number of days of antibiotic treatment for pneumonia within the first 30 days 3. Neurological recovery measured using the National Institutes of Health Stroke Scale (NIHSS) at 30 days 4. Disability measured using the modified Rankin Scale (mRS) at 90 days 5. Quality of life measured using the EuroQol five dimensions questionnaire (EQ-5D) at 90 days | — |
Countries
United Kingdom
Outcome results
None listed