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Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

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ClinicalTrials.gov Identifier: NCT04873297
Recruitment Status : Completed
First Posted : May 5, 2021
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Muhammad Hassan, Shaheed Zulfiqar Ali Bhutto Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Stroke Aspiration Pneumonia Drug: Metoclopramide 10mg Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes
Actual Study Start Date : May 2, 2021
Actual Primary Completion Date : October 2, 2021
Actual Study Completion Date : October 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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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 Name: Water


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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]


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873297


Locations
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Pakistan
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, Pakistan, 44000
Sponsors and Collaborators
Shaheed Zulfiqar Ali Bhutto Medical University
Investigators
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Principal Investigator: Muhammad Hassan, MD Shaheed Zulfiqar Ali Bhutto Medical University
More Information
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Responsible Party: Muhammad Hassan, Resident in Neurology, Shaheed Zulfiqar Ali Bhutto Medical University
ClinicalTrials.gov Identifier: NCT04873297    
Other Study ID Numbers: Metoclopramide in Stroke
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Aspiration
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action