Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Aspiration Pneumonia; Acute Stroke
• Intervention / Treatment: Drug: Metoclopramide 10mg; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metoclopramide Group; One group will be given metoclopramide 10mg TDS	Drug: Metoclopramide 10mg; Tab. Metoclopramide 10mg TDS via NG tube; Other Names: Metomide; Metoclop
Placebo Comparator: Placebo Group; This group will be given placebo (normal saline 10ml via NG TDS)	Drug: Placebo; Placebo 10 ml of plain water Via NG; Other Names: Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of episodes of aspiration pneumonia	Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with swallowing improved +NGT removed	During admission patient's swallowing with improved and NG tube removed.	7 days
Number of participants with treatment withdrawn and NGT removed	Patient's swallowing with improved and treatment withdrawn and NG tube removed.	7 days
New onset of Fever	Aspiraton pneumonia will be assess in terms of fever (>98.6F)	7 days
Leukocytosis	Aspiration pneumonia will be assess in terms of leukocytosis on blood counts [ TLC >12000/uL]	7 days
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

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
• Investigators: Principal Investigator: Muhammad Hassan, MD, Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2021
• Primary Completion (Actual): October 2, 2021
• Study Completion (Actual): October 2, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Stroke; Pneumonia; Pneumonia, Aspiration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: Metoclopramide in Stroke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No