According to this fact that hospitalized patients in Intensive Care Unit (ICU) are susceptible to stress ulcer, they are given Ranitidin or Pantoprazol routinely. These two drugs not only prevent stress ulcer but also have effect in preventing from Ventilator Associated Pneumonia (VAP). In this study we compare this effect of these two drugs.180 intubated hospitalized patients in Imam Reza Emergency Department who are connected to mechanical ventilator and have no active lung disease are chosen. They will continue their treatment in ICU. They are divided into two groups: group A: 90 patients, group B: 90 patients. These two groups treatment with Ranitidin or Pantoprazol is started from the first day of hospitalization in ED and will continue until the end of hospitalization time in ICU. Routinely and weekly a CXR will be taken for showing new opacities until the releasing time. Diagnostic criteria for VAP are: new infiltration in CXR plus two criteria of these three criteria: 1.fever higher than 38.5, 2.leukocytes more than 100000, 3.pus in suctioning the tracheal tube secretion. The final diagnosis for VAP is based on the culture of the tracheal tube secretion. The existence of more than 100000 bacterial colony counts will be positive. The incidence of VAP in the specific period of time will be documented and the results will be given to the statistician specialist for analysis.
General information
Acronym
ventilator_associated pneumonia
IRCT registration information
IRCT registration number:IRCT2014112611956N3
Registration date:2015-03-16, 1393/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-16, 1393/12/25
Registrant information
Name
Morteza Talebi Doluee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
talebidm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of of ranitidine and pantoprazole on the occurrence of ventilated associated pneumonia
Public title
Comparing the effect of of ranitidine and pantoprazole on the occurrence of ventilated associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteriona: hospitalized intubated patients in intensive care unit of Imam Reza hospital during the study. Exclusion criteria: patients showing allergic reactions to ranitidin and pantoprazol; patients with active lung disease before receiving these two drugs; patients with active gastrointestinal bleeding at the beginning of our study; immune compromised patients or the history of receiving antibiotics or any factor that changes the immune condition toward VAP.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
Postal code
913753316
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
930275
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
Decreased incidance of ventilator associated pneumonia in intubated patients under mechanical ventilation
Timepoint
End of stay in the ICU
Method of measurement
Diagnostic criteria for VAP are: new infiltration in CXR plus two criteria of these three criteria:1.fever higher than 38.5,2.leukocytes more than 100000,3.pus in suctioning the tracheal tube secretion.the final diagnosis for VAP is based on the culture of the tracheal tube secretion.the existence of more than 100000 bacterial colony count will be positive
Secondary outcomes
1
Description
Fever more than 38.5 degree
Timepoint
Every day
Method of measurement
Thermometer
2
Description
Lekusytosis more than 10000
Timepoint
Every day
Method of measurement
CBC
3
Description
Colony count more than 100000 in tracheal tube culture
Timepoint
Every day
Method of measurement
Tracheal tube specimen culture
4
Description
New infiltration in CXR
Timepoint
Every week
Method of measurement
Chest X Ray
Intervention groups
1
Description
First group(intervention): 90 patients; from the beginning until the end of hospitalization intravenous Ranitidine 50 mg will be given three times a day and after tolerating oral nutrition will be continued 150 mg twice a day.
Category
Treatment - Drugs
2
Description
Second group (control):90 patients; starting treatment with intravenous pantoprazole 40Mg twice a day from the beginning of hospitalization and will be continued until the releasing time. After tolerating oral nutrition pantoprazole 40mg oral will be given to patients through nasogastric tube (intracapsular granules are extracted and washed with 20 cc water through nasogastric tube).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU, Imam Reza Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreishi building, Mashhad University of Medical Sciences, Daneshgah street,
City
Mashhad
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Sara Rozmina
Position
MD, Resident of emergency medicine
Other areas of specialty/work
Street address
Emergency Department Office, Imam Reza Hospital,Razi Street
City
Mashad
Postal code
Phone
+98 51 3852 5312
Fax
Email
sararozmina@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Morteza Talebi Deloie
Position
Emergency Medicine speacilist, Assistant professer
Other areas of specialty/work
Street address
Emergency Department Office, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5831
Fax
Email
talebidm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Sara Rozmina
Position
MD, Resident of Emergency Medicine
Other areas of specialty/work
Street address
Emergency Department Office, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3605 3313
Fax
Email
sararozmina@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)