The aim of this study was to compare the effect of Ranitidine and Sucralfate on the decrease in the incidence of ventilator-associated pneumonia in patients admitted to the intensive care unit. This is a randomized double-blinded clinical trial performed in two groups of 74. Inclusion criteria: patients aged between 15 and 75 years old ; men or women ; has the sofa score 4 to 10 at the time of admission; require intubation for more than 48 hours.
Exclusion criteria : History of recent pulmonary infection or gastrointestinal bleeding; Early discharge of ICU ; Extubation less than 48 hours ; Patients Has any immunodeficiency.
Population is categorized randomly into two groups. group A, Sucralfate dose of 1 g, every 6 hours and the B group Ranitidine with a dose of 150 mg every 8 hours will be given.
In order to diagnose VAP, Centers for Disease Control and Prevention (CDC) pneumonia are compared in two groups. Patients should withdraw from the study until 8 days after intubation and then decide on diagnosis.
General information
Acronym
VAP: ventilator-associated pneumonia
IRCT registration information
IRCT registration number:IRCT2017080835577N1
Registration date:2017-10-10, 1396/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-10, 1396/07/18
Registrant information
Name
Amin Yousefelahi
Name of organization / entity
Anesthesiology gruop of rafsanjan
Country
Iran (Islamic Republic of)
Phone
+98 343523400
Email address
ayousefelahi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research & technology of Rafsanjan university of medical sciences.
Expected recruitment start date
2014-08-27, 1393/06/05
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Ranitidine and Sucralfate on the incidence of ventilator-associated pneumonia in ICU patients.
Public title
Effect of Ranitidine and Sucralfate on the incidence of ventilator-associated pneumonia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 15 and 75 years old ; men or women ; has the sofa score 4 to 10 at the time of admission; require intubation for more than 48 hours.
Exclusion criteria : History of recent pulmonary infection or gastrointestinal bleeding; Early discharge of ICU ; Extubation less than 48 hours ; Patients Has any immunodeficiency.
Age
From 14 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee vice chancellor for research & technology of Rafsanjan Univercity of Medical Scienc
Street address
Research and Technology Dept. Building No. 3, Central Office of Rafsanjan University of Medical Sciences Rafsanjan, Imam Ali Blvd.
City
rafsanjan
Postal code
Approval date
2016-01-27, 1394/11/07
Ethics committee reference number
IR.RUMS.REC.1394.11
Health conditions studied
1
Description of health condition studied
ventilator-associated pneumon
ICD-10 code
J95.8
ICD-10 code description
Other postprocedural respiratory disorders
Primary outcomes
1
Description
Amount of serum ESR
Timepoint
Daily for 6 days
Method of measurement
Serum ESR test
2
Description
Amount of serum white blood cells
Timepoint
Daily for 6 days
Method of measurement
Cell blood count test
3
Description
Amount of arterial oxygen concentration
Timepoint
Daily for 6 days
Method of measurement
Arterial blood gas
4
Description
Type of Nasotracheal discharge
Timepoint
Daily for 6 days
Method of measurement
Nasotracheal discharge culture
5
Description
Incidence of VAP
Timepoint
Daily for 6 days
Method of measurement
culture of discharge
Secondary outcomes
1
Description
Amount of body temperature
Timepoint
Every 12 hours for 6 days
Method of measurement
With sub axillary thermometer
2
Description
Amount of serum cratinin
Timepoint
Daily for 10 days
Method of measurement
Serum cratinin test
Intervention groups
1
Description
Tablet Sucralfate 1 gram, 1 gram per 6 hours, for 10 days, made by Kimidaru co.
Category
Treatment - Drugs
2
Description
Tablet Ranitidine 150 mg, 150 mg every 8 hours, for 10 days, made by Kimidaru co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Anesthesiology Department of Ali ibn Abitaleb Hospital
Full name of responsible person
Street address
City
rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research & technology of Rafsanjan University of Medical Sciences
Full name of responsible person
Monavar Naderi
Street address
Research and Technology Dept. Building No. 3, Central Office of Rafsanjan University of Medical Sciences Rafsanjan, Imam Ali Blvd.
City
rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research & technology of Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Rafsanjan University of Medical Sciences
Full name of responsible person
Amin Yousefelahi
Position
medical intern
Other areas of specialty/work
Street address
Andishe street, blvd Jomhuri eslami
City
kerman
Postal code
Phone
+98 34 3281 2985
Fax
Email
ayousefelahi@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Pakzad
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology Rafsanjan University of Medical Sciences, Ali ibn Abi Talib Hospital
City
Rafsanjan
Postal code
Phone
+98 34 3428 0000
Fax
Email
pakzadmoghadam@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Amin Yousefelahi
Position
Medical intern
Other areas of specialty/work
Street address
Andishe street, Jomhuri eslami blvd
City
Kerman
Postal code
Phone
+98 34 3281 2985
Fax
Email
ayousefelahi@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)