Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Acute Stroke Clinical Trial

Official title:

Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873297
• Other study ID #: Metoclopramide in Stroke
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2021
• Est. completion date: October 2, 2021

Study information

• Verified date: October 2021
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pneumonia is a major cause of mortality and morbidity in patients with acute stroke fed via nasogastric tubes and may be because of vomiting and gastro-esophageal regurgitation. The aim of the study was to assess whether regular treatment with metoclopramide, a D2-receptor antagonist with antiemetic and gastric prokinetic actions, could reduce the rate of pneumonia.

Description:

Patients admitted with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube will be recruited into a single-blind randomized placebo-controlled study who will admit in Neurology Department, PIMS. Participants will receive metoclopramide 10 mg or placebo 3 times daily via the nasogastric tube for 4 days. Clinical signs of pneumonia will be recorded on alternate days. Pneumonia will be diagnosed if the patient has relevant clinical signs, high inflammatory markers, and new infiltrates on the chest radiograph. A sample size of 106 patients is calculated, 53 patients in each group. Non-probability consecutive sampling will be used for recruitment of participants. Study duration will be six months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2, 2021
• Est. primary completion date: October 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients of either gender.

2. Patients within 7 days of acute ischemic or hemorrhagic stroke confirmed by computed tomographic scan of the brain who required nasogastric feeds for >24 hours, and could be recruited within 48 hours of NGT insertion

3. Age above 13 years.

Exclusion Criteria:

• Patients with aspiration pneumonia at the time of presentation.
• Patients with a history of chronic neurodegenerative diseases that could affect swallowing (e.g. Parkinson disease and motor neuron disease)
• Poor postural control (unable to sit up for swallowing assessment).
• Esophageal disorders,
• Contraindications to metoclopramide.

Related Conditions & MeSH terms

• Acute Stroke
• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration
• Stroke

Intervention

Drug:
• Metoclopramide 10mg
Tab. Metoclopramide 10mg TDS via NG tube
• Placebo
Placebo 10 ml of plain water Via NG

Locations

Country	Name	City	State
Pakistan	Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of aspiration pneumonia	Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.	7 days
Secondary	Number of participants with swallowing improved +NGT removed	During admission patient's swallowing with improved and NG tube removed.	7 days
Secondary	Number of participants with treatment withdrawn and NGT removed	Patient's swallowing with improved and treatment withdrawn and NG tube removed.	7 days
Secondary	New onset of Fever	Aspiraton pneumonia will be assess in terms of fever (>98.6F)	7 days
Secondary	Leukocytosis	Aspiration pneumonia will be assess in terms of leukocytosis on blood counts [ TLC >12000/uL]	7 days
Secondary	Aspiration Pneumonia	Treatment with metoclopramide in patients with acute stroke is hypothesized to prevent aspiration pneumonia and pneumonia will be assess in terms of new findings on chest x-ray of patients [The posterior segment of the upper lobes and the superior segment of the lower lobes are most commonly involved lung sites when aspiration occurs in a recumbent patient. In an erect patient, aspiration is more likely to involve bilateral basal segments, middle lobe, and lingula- new exudate, new pleural effusion and new infiltrates]	7 days