Comparison Ventilator Associated Pneumonia in two groups of adult ICU patients under prophylactic treatment by intravenous Pantoprazole or intravenous Ranitidine
Objectives: To investigate the incidence of ventilator associated pneumonia (VAP) in both groups of the study treated with prophylactic intravenous Pantoprazole and Ranitidine; Research Design: Conduction of a randomized, double-blind, clinical trial, method of randomization: simple randomization by computer; Major Inclusion Criteria: Patients aged 18 or over with no history of pneumonia within three months prior to or at the time of admission and no history of gastrointestinal bleeding, reflux, and immunodeficiency; Major Exclusion Criteria: Drug intervention, renal failure, and gastrointestinal bleeding; Sample Size: 166 patients found eligible based on the inclusion criteria; Interventions: Pantoprazole 40 mg will be used twice a day for the experimental group. While, Ranitidine 50 mg will be administered three times a day for the control group. Then, the patients will be evaluated in terms of ventilator associated pneumonia that will be diagnosed based on the clinical symptoms, pulmonary infection scoring system, and sputum culture; Time of the Intervention: Immediately after the admission of the qualified patients into the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072014079N1
Registration date:2013-12-28, 1392/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-28, 1392/10/07
Registrant information
Name
Hajar Faghihi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1228 9620
Email address
faghihih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2013-06-17, 1392/03/27
Expected recruitment end date
2014-06-17, 1393/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Ventilator Associated Pneumonia in two groups of adult ICU patients under prophylactic treatment by intravenous Pantoprazole or intravenous Ranitidine
Public title
Comparison of Pantoprazole and Ranitidine for preventing pulmonary infection in ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
1. 18 Years of age and over
2. Intubation for more than 48 hours
3. No history of pneumonia within 3 months prior to or at the time of admission
4. No history of severe dysphagia
5. No history of deficiency in the immune system
6. No history of gastrointestinal bleeding
7. No history of gastrectomy, erosive gastritis, and reflux
8. No history of lung cancer
9. No transferring of patients from other ICUs.
Exclusion Criteria:
1. Renal failure
2. Drug interference
3. Incidence of drug side effects
4. Gastrointestinal bleeding.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
166
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 of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences- Zand Street- Shiraz- Fars- Iran
City
Shiraz
Postal code
Approval date
2013-06-16, 1392/03/26
Ethics committee reference number
CT-P-92-4227
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
2
Description of health condition studied
GI bleeding
ICD-10 code
K92.2
ICD-10 code description
K92.2 is a billable ICD-10-CM code that can be used to specify a diagnosis.
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
Daily until the sputum is positively cultured or 48 hours after extubation
Observing the coffee grain contents in the naso- or oro-gastric tube and Melena; checking vital signs such as blood pressure and heart rate, and hemoglobin
2
Description
Length of stay in ICU
Timepoint
At the end
Method of measurement
Observation
3
Description
Mortality in ICU
Timepoint
At the end
Method of measurement
Observation
4
Description
Mortality in ward
Timepoint
At the end
Method of measurement
Observation
5
Description
Duration of Mechanical Ventilation
Timepoint
Since the start of mechanical ventilation until the patient is disconnected from the machine.
Method of measurement
Observation
Intervention groups
1
Description
In the Experimental Group: Pantoprazole 40 mg ampoule is administrated intravenously every 12 hours until the patient is infected with pneumonia; the procedure continues for up to 48 hours following extubation. Manufacturing Company: Nycomed, Germany; Brand name: Pantazol.
Category
Prevention
2
Description
In the Control Group: Ranitidine 50 mg is administrated intravenously every 8 hours until the patient is infected with pneumonia; the procedure continues for up to 48 hours following extubation. Manufacturing Company: Alborze darou.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency ICU- Nemazee Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
General ICU- Nemazee Hospital
Full name of responsible person
Street address
City
Shiraz
3
Recruitment center
Name of recruitment center
Central ICU- Nemazee Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Vice chancellor for research, Shiraz University of Medical Sciences- 7th floor- Central Building of Shiraz University of Medical Sciences- Zand Street
City
Shiraz
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, Shiraz 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
Shiraz University Medical Sciences
Full name of responsible person
Hajar Faghihi
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 1228 9620
Fax
Email
hajarfaghihi@gmail.com faghihih@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farid Zand
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
Email
Zandf@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Faghihi
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 1228 9620
Fax
Email
hajarfaghihi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)