Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873297
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2021-04-29
Brief Title:
Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke
Sponsor:
Shaheed Zulfiqar Ali Bhutto Medical University
Organization:
Shaheed Zulfiqar Ali Bhutto Medical University
Study Overview
Official Title:
Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None