Metoclopramide for avoiding pneumonia after stroke

Phase 3

• Conditions: Prevention of pneumonia caused by dysphagia after an acute stroke; Digestive System

• Registration Number: ISRCTN40512746
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-17
• Last Update Posted: 15 April 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified