Clinical trial NCT04873297: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Stroke
Aspiration Pneumonia
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of episodes of aspiration pneumonia
timeFrame: 7 days
Secondary outcomes:
measure: Number of participants with swallowing improved +NGT removed
timeFrame: 7 days
measure: Number of participants with treatment withdrawn and NGT removed
timeFrame: 7 days
measure: New onset of Fever
timeFrame: 7 days
measure: Leukocytosis
timeFrame: 7 days
measure: Aspiration Pneumonia
timeFrame: 7 days
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Muhammad Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: