Objective:
Comparing the effect of Ranitidin and Pantoprazole on ventilator associated pneumonia (VAP) in trauma patients admitted in ICU.
Design: Double blind clinical trial
Population: Patients entered the study during one year from traumatic patients (multiple trauma and head trauma) who were admitted in ICU .
Inclusion criteria: patients who required mechanical ventilation>48h and were admitted to the ICU, aged more than 18 years old, with APACHE SCORE II less than 25. Exclusion criteria: history of GI bleeding, liver or kidney insufficiency, APACHESCOREII>25، History of corticosteroids or NSAIDs usage, Under mechanical ventilation less than 48 hours.
Intervention: In control group,(ranitidine gruop),Amp ranitidine will prescribe 50mg twice daily; and in intervention group(pantoprazole);Amp pantoprazole will prescribe 40mg once daily.
Patients will be evaluated in terms of getting vap.
Vap diagnosis based on clinical signs and forms will be available.
Intervention is performed immediately after admission.
Primary outcome is ventilator associated pneumonia .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109234578N3
Registration date:2011-10-07, 1390/07/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-10-07, 1390/07/15
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences-vice chancellor for research
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Ranitidin and Pantoprazole on ventilator associated pneumonia (VAP) in trauma patients admitted in ICU of Be'sat hospital
Public title
Ranitidine and pantoprazole in prevention of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:
Trauma patients undergoing mechanical ventilation for more than 48 hours, Age>18y، Admitted in ICU، APACHESCOREII<25، At admission dont have GI bleeding
exclusion:
A history of GI bleeding, renal and hepatic failure,APACHESCOREII>25، History of corticosteroids or NSAIDs usage,Under mechanical ventilation less than 48 hours, Age<18y.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Hamedan University Of Medical Sciences
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Approval date
2011-07-27, 1390/05/05
Ethics committee reference number
16/35/9/1649/پ/د
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae
2
Description of health condition studied
pneumonia
ICD-10 code
J14
ICD-10 code description
Pneumonia due to Haemophilus influenzae
3
Description of health condition studied
pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
ventilator associated pneumonia
Timepoint
daily
Method of measurement
1- radiographic criteria(The presence of a new or progressive radiographic infiltrate or cavitation).2-clinical characteristics such as :fever , leukocytosis or leukopenia, and purulent secretions thar require Suction.3-Laboratory criteria:Positive throat &blood culture
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group Pantoprazol 40 mg once a day will infuse till to end of patient admission
Category
Prevention
2
Description
In control group Ranitidine 50 mg twice a day will infuse till to end of patient admission.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Farshid Rahimi Bashar
Street address
BESAT Hospital, General ICU, Motahhari Avenue_Resalat square-Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences-vice chancellor for research
Full name of responsible person
Ali GHaleiha
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences-vice chancellor for research
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor/Intensive care fellowship
Other areas of specialty/work
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
fr_rahimibashar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor/Intensive care fellowship
Other areas of specialty/work
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
fr_rahimibashar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)