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Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Primary Purpose

Acute Stroke, Aspiration Pneumonia

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Metoclopramide 10mg
Placebo
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaheed Zulfiqar Ali Bhutto Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metoclopramide Group

Placebo Group

Arm Description

One group will be given metoclopramide 10mg TDS

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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Number of participants with treatment withdrawn and NGT removed
Patient's swallowing with improved and treatment withdrawn and NG tube removed.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

Full Information

First Posted
April 29, 2021
Last Updated
October 18, 2021
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04873297
Brief Title
Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke
Official Title
Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
October 2, 2021 (Actual)
Study Completion Date
October 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke, Aspiration Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metoclopramide Group
Arm Type
Experimental
Arm Description
One group will be given metoclopramide 10mg TDS
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
This group will be given placebo (normal saline 10ml via NG TDS)
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10mg
Other Intervention Name(s)
Metomide, Metoclop
Intervention Description
Tab. Metoclopramide 10mg TDS via NG tube
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Water
Intervention Description
Placebo 10 ml of plain water Via NG
Primary Outcome Measure Information:
Title
Number of episodes of aspiration pneumonia
Description
Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of participants with swallowing improved +NGT removed
Description
During admission patient's swallowing with improved and NG tube removed.
Time Frame
7 days
Title
Number of participants with treatment withdrawn and NGT removed
Description
Patient's swallowing with improved and treatment withdrawn and NG tube removed.
Time Frame
7 days
Title
New onset of Fever
Description
Aspiraton pneumonia will be assess in terms of fever (>98.6F)
Time Frame
7 days
Title
Leukocytosis
Description
Aspiration pneumonia will be assess in terms of leukocytosis on blood counts [ TLC >12000/uL]
Time Frame
7 days
Title
Aspiration Pneumonia
Description
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]
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Hassan, MD
Organizational Affiliation
Shaheed Zulfiqar Ali Bhutto Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaheed Zulfiqar Ali Bhutto Medical University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

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