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Completed

NCT Number: NCT04873297

Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

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.

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Key information

Conditions

Acute Stroke Aspiration Pneumonia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infections Lung Diseases Nervous System Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Metoclopramide 10mg

Drug

Tab. Metoclopramide 10mg TDS via NG tube

Other names: Metomide, Metoclop

Placebo

Drug

Placebo 10 ml of plain water Via NG

Other names: Water

Primary outcomes

  1. Number of episodes of aspiration pneumonia

    Time frame: 7 days

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

Secondary outcomes

  1. Number of participants with swallowing improved +NGT removed

    Time frame: 7 days

    During admission patient's swallowing with improved and NG tube removed.

  2. Number of participants with treatment withdrawn and NGT removed

    Time frame: 7 days

    Patient's swallowing with improved and treatment withdrawn and NG tube removed.

  3. New onset of Fever

    Time frame: 7 days

    Aspiraton pneumonia will be assess in terms of fever (>98.6F)

  4. Leukocytosis

    Time frame: 7 days

    Aspiration pneumonia will be assess in terms of leukocytosis on blood counts [ TLC >12000/uL]

  5. Aspiration Pneumonia

    Time frame: 7 days

    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]

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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