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Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04873297
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
21.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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.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 :
Oct 2, 2021
Actual Study Completion Date :
Oct 2, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of episodes of aspiration pneumonia [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 [7 days]

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

    2. Number of participants with treatment withdrawn and NGT removed [7 days]

      Patient's swallowing with improved and treatment withdrawn and NG tube removed.

    3. New onset of Fever [7 days]

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

    4. Leukocytosis [7 days]

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

    5. Aspiration Pneumonia [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan 44000

    Sponsors and Collaborators

    • Shaheed Zulfiqar Ali Bhutto Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Pneumonia
    Pneumonia, Aspiration
    Stroke
    Metoclopramide

    Study Results

    No Results Posted as of Oct 19, 2021