Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

NCT04873297 | Completed Phase 4

• 1 other identifier: Metoclopramide in Stroke
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Stroke; Aspiration Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of episodes of aspiration pneumonia

  Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.

  7 days

Secondary Outcomes (5)

• Number of participants with swallowing improved +NGT removed

  7 days

• Number of participants with treatment withdrawn and NGT removed

  7 days

• New onset of Fever

  7 days

• Leukocytosis

  7 days

• Aspiration Pneumonia

  7 days

Study Arms (2)

Metoclopramide Group

EXPERIMENTAL

One group will be given metoclopramide 10mg TDS

Drug: Metoclopramide 10mg

Placebo Group

PLACEBO COMPARATOR

This group will be given placebo (normal saline 10ml via NG TDS)

Drug: Placebo

Interventions

Metoclopramide 10mg DRUG

Tab. Metoclopramide 10mg TDS via NG tube

Also known as: Metomide, Metoclop

Metoclopramide Group

Placebo DRUG

Placebo 10 ml of plain water Via NG

Also known as: Water

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender.
• 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
• Age above 13 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke; Pneumonia, Aspiration

Interventions

Metoclopramide; Trimethoprim, Sulfamethoxazole Drug Combination; Water

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Muhammad Hassan, MD

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Neurology

Model Details: After taking permission from the Hospital Ethical Committee this study will be conducted at the Neurology department of PIMS. After informed written consent, all patients admitted to the Neurology ward with acute stroke on the basis of the clinical and radiologic evidence as defined in the operational definition will undergo detailed history and neurological examination. Patients beings grouped into 2 subgroup via lottery method. One group is given metoclopramide and one group will be given placebo (normal saline). SPSS version 23 will be used for data analysis. Post stratification chi square test will be applied. P value ≤0.05 will be considered significant.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 5, 2021
• Study Start: May 2, 2021
• Primary Completion: October 2, 2021
• Study Completion: October 2, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)