The aim of this study was to evaluate the effect of domperidone on the prevention of pneumonia in patients with stroke.
Design
In this clinical trial, 170 patients with clinical signs and radiological findings of stroke were included in the study. Patients were randomly divided into two groups of 85 patients. The first group received 10 mg of Dopyridone tablets daily and the control group received placebo tablets every 12 hours. The study is a blind study and trial phase 3. Randomization is performed using random sequence generation software. In this way, information such as sample size and number of groups is given to the software and the software provides a table of random numbers, each of which is randomly assigned the letters A and B. In this study, A numbers are in the intervention group and B numbers are in the control group.
Settings and conduct
In this one-way blind clinical trial, 170 patients with clinical signs and radiological findings of stroke in Qazvin Bu Ali Sina Hospital were enrolled. In order to blind the patient, placebo is used instead of dompiridone in the control group and patients do not know about the prescribed drug (placebo and drug).
Participants/Inclusion and exclusion criteria
Inclusion criteria: clinical signs of acute stroke; Radiological findings of acute stroke
Exclusion criteria: underlying lung disease; Lung structural disorders; Recent use of prokinetics; Pregnancy; History of previous pneumonia; Immunosuppression.
Intervention groups
One group is given 10 mg of Dopyridone tablets and the other group is given a placebo every 12 hours during the hospital stay.
Main outcome variables
Need for intubation; Duration of hospitalization; Start oral feeding; Nutrition tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201001048896N1
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
somaieh kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 2930
Email address
somaiehkiani7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Domperidone in the prevention of pneumonia in patients with stroke
Public title
Evaluation of the effect of Domperidone in the prevention of lung infection in patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical signs of acute stroke
Radiological findings of acute stroke
Exclusion criteria:
Underlying lung disease
Lung structural disorders
Recent use of prokinetics
Pregnancy
History of previous pneumonia
Immunosuppression
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the ease of use and cost savings in time, participants were divided into two groups using random sequence generation software. In this way, information such as sample size and number of groups is given to the software and the software provides a table of random numbers, each of which is randomly assigned the letters A and B. In this study, A numbers are in the intervention group and B numbers are in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was performed blindly. In this study, patients do not know about prescription drugs (placebo and drugs). In order to blind the patient, placebo is used in the control group instead of Dopiridone.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2019-12-30, 1398/10/09
Ethics committee reference number
IR.QUMS.REC.1398.258
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J17
ICD-10 code description
Pneumonia in diseases classified elsewhere
Primary outcomes
1
Description
Clinical signs
Timepoint
At admission, 48 hours after taking the drug, at discharge
Method of measurement
Physical examination
Secondary outcomes
1
Description
Requires intubation
Timepoint
Duration of hospitalization
Method of measurement
Physical examination
2
Description
Duration of hospitalization
Timepoint
Patient discharge day
Method of measurement
Physical examination
3
Description
Start feeding orally
Timepoint
During the patient's hospitalization
Method of measurement
Physical examination
4
Description
Nutrition tolerance
Timepoint
During the patient's hospitalization
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Take Dompiridone 10 mg tablet every 12 hours during hospitalization
Category
Treatment - Drugs
2
Description
Control group: Take placebo tablet every 12 hours during hospitalization
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo-Ali Hospital
Full name of responsible person
Somaieh Kiani Majd
Street address
Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
somaiehkiani7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Emamjomeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Somaieh Kiani Majd
Position
Resident of Infectious Diseases
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
somaiehkiani7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Abbas Allami
Position
Professor of Infectious Disease
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
allami9@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Somaieh Kiani Majd
Position
Resident of Infectious Diseases
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
somaiehkiani7@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information is the most commonly used questionnaire, which is a statistical analysis
When the data will become available and for how long
Starting 1 years after publication .
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Path analysis
From where data/document is obtainable
Dr Somaieh Kiani Majd
What processes are involved for a request to access data/document
The email will be submitted to the project promoter at the discretion of the information.