A clinical trial to compare the effects of ranitidine, pantoprazole, and sucralfate on the prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation.
To compare the effects of ranitidine, pantoprazole, and sucralfate on the prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation.
Design
In this double-blinded clinical trial with a control group, 87 children under mechanical ventilation for more than 48 hours will be selected as parallel groups using a table of random numbers.
Settings and conduct
The children under mechanical ventilation for more than 48 hours at the pediatric intensive care unit in Doctor Sheikh and Akbar Children's hospitals are selected in this study. In this double-blind study, the clinical care and those who are responsible for data collection are blind to the patients groups and the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients admitted to the pediatric care unit who have been under ventilation for at least 48 hours.
Exclusion criteria: Hospital stay or mechanical ventilation less than 48 hours, gastrointestinal bleeding before the onset of the treatment, ventilator-associated pneumonia before the onset of the treatment.
Intervention groups
The first intervention group will receive 4 mg/kg/day of intravenous ranitidine 3 times per day. The second group will receive 1 mg/kg/day of intravenous pantoprazole 2 times per day. Moreover, the third group will receive 60 mg/kg/day of oral sucralfate 4 times per day.
Main outcome variables
The three intervention groups will be evaluated and compared regarding the rate of ventilator-associated pneumonia, gastrointestinal bleeding, upper airway colonization, hospital stay in the intensive care unit, and mortality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190522043672N1
Registration date:2020-01-18, 1398/10/28
Registration timing:prospective
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Majid Sezavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 9225
Email address
sezavardm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effects of ranitidine, pantoprazole, and sucralfate on the prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation.
Public title
Prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patients admitted to the pediatric care unit who have been under ventilation for at least 48 hours.
Exclusion criteria:
Hospital stay or mechanical ventilation less than 48 hours
Gastrointestinal bleeding before the onset of the treatment,
Ventilator-associated pneumonia before the onset of the treatment
Age
From 1 month old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 29 patients with blocks of 2, 4 and 6 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sample selection based on a statistical analysis system (SAS), computer software. Sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The children under mechanical ventilation for more than 48 hours at the pediatric intensive care unit in Doctor Sheikh and Akbar Children's hospitals are selected in this study. In this double-blind study, sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. The clinical care and those who are responsible for data collection are blind to the patients groups and the type of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.691
Health conditions studied
1
Description of health condition studied
Gastrointestinal bleeding
ICD-10 code
T47.8
ICD-10 code description
Other agents primarily affecting the gastrointestinal system
2
Description of health condition studied
Ventilator-associated pneumonia
ICD-10 code
J84.9
ICD-10 code description
Interstitial pulmonary disease, unspecified
Primary outcomes
1
Description
The rate of ventilator-associated pneumonia
Timepoint
48 hours after intervention
Method of measurement
chest radiograghy
2
Description
The rate of gastrointestinal bleeding
Timepoint
48 hours after intervention
Method of measurement
Blood in stool and vomit
Secondary outcomes
1
Description
Upper airway colonization
Timepoint
48 hours after intervention
Method of measurement
Microbiological culture
2
Description
Hospital stay in the intensive care unit
Timepoint
After intervention
Method of measurement
Questionnaire
3
Description
The rate of mortality
Timepoint
After intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: Who will receive 4 mg/kg/day of intravenous ranitidine 3 times per day.
Category
Prevention
2
Description
Intervention group 2: Who will receive 1 mg/kg/day of intravenous pantoprazole 2 times per day.
Category
Prevention
3
Description
Intervention group 3: Who will receive 60 mg/kg/day of oral sucralfate 4 times per day.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Majid Sezavar
Street address
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595100
Phone
+98 51 3870 9225
Email
iomresearch@mums.ac.ir
2
Recruitment center
Name of recruitment center
Doctor Sheikh Hospital
Full name of responsible person
Majid Sezavar
Street address
Doctor Sheikh Hospital, Taheri Street, Tohid Square
City
Mashhad
Province
Razavi Khorasan
Postal code
71348714737
Phone
+98 51 3726 9021
Email
Sheikh.Hos@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Sezavar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595100
Phone
+98 51 3870 9225
Email
sezavardm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Sezavar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595100
Phone
+98 51 3870 9225
Email
sezavardm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Sezavar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595100
Phone
+98 51 3870 9225
Email
sezavardm@mums.ac.ir
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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Majid Sezavar provides the analysis code to the applicants via email: sezavardm@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week