To compare the effect of metoclopramide and erythromycin on the occurrence aspiration pneumonia in mechanically ventilated patients
Design
Phase III assessor-blind randomized trial with parallel groups on 150 patients, block randomization with a block size of 4 based on the randomization table generated by the Randomization Main software.
Settings and conduct
This study will be performed on 150 intubated patients under mechanical ventilation admitted to the trauma and internal ICUs of Bandar Abbas Shahid Mohammadi Hospital. The patients will be randomized into two groups by block randomization. Intervention group 1 will receive metoclopramide 10 mg every 8 hours and the intervention group 2 erythromycin 50 mg every 6 hours.
The occurrence of aspiration pneumonia will be assessed within 72 hours by assessors blinded to patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 17-70 years, intubated patients under mechanical ventilation, admission to ICU
Exclusion criteria: underlying pulmonary disease, pulmonary contusion, pulmonary emboli, pneumonia on admission, corticosteroid use, cardiopulmonary arrest, acute respiratory distress syndrome due to extrapulmonary causes, end-stage renal disease
Intervention groups
Intervention group 1: Metoclopramide 10 mg every 8 hours
Intervention group 2: Erythromycin 50 mg every 6 hours
Main outcome variables
Aspiration pneumonia rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058512N1
Registration date:2023-07-19, 1402/04/28
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Mohsen Sarafikhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
dr.sarafikhah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of metoclopramide and erythromycin on aspiration pneumonia in intubated patients under mechanical ventilation
Public title
Metoclopramide versus erythromycin for the reduction of aspiration pneumonia in mechanically ventilated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 17-70 years
Intubated patients under mechanical ventilation
Admitted to the ICU
Exclusion criteria:
Underlying pulmonary disease
Pulmonary contusion
Pulmonary emboli
Pneumonia on admission
Corticosteroid use
Cardiopulmonary arrest
Acute respiratory distress syndrome due to extrapulmonary causes
end-stage renal disease
Age
From 17 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with a block size of 4 based on the randomization table generated by the Randomization Main software, without allocation concealment, so that 150 patients will be divided into 36 blocks of 4 and 2 blocks of 3, and each block of 4 and then 2 blocks of 3 will be randomly assigned to one of the groups according to the table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Aspiration pneumonia will be diagnosed based on clinical and imaging findings by ICU subspecialists and a pulmonologist who will be blinded to patient grouping; therefore, this will be an assessor-blind trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Faculty of Medicine, Across from Kargaran Sports Complex, Imam Hossein Blvd.