The aim of the study is to determine effect of probiotic preparation, lactocare, on ventilator associated pneumonia incidence in the critically ill patients. After approval of the ethical committee of the university, 80 patients aging more than 80 years and undergoing mechanical ventilation will be enrolled in the study. An informed consent will be taken from the patients or their legal guardians to enter them in the study. All patients will receive standard treatment based on their disease. They will also receive assistance therapy. They will randomly be divided into two groups. The first group will receive standard and common treatment. They will also receive enteral Lactocare capsules every 12 hours. The second group will receive standard treatment plus placebo. The study will take on for a week. During this time, the vital signs and patient information (age, gender, number of aspiration per day, number of days under mechanical ventilation, mortality and APACHE II score will be recorded. All patients will have throat secretion at the beginning. Afterwards, it will be repeated twice during the study and after extubation. Throat secretion will be assessed by microbiological tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411182582N10
Registration date:2014-12-22, 1393/10/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic preparation, lactocare, on incidence of ventilator associated pneumonia in critically ill patients
Public title
Effect of lactocare on pneumonia in critically ill patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: patients aging more than 18 years old and needing mechanical ventilation for a period of more than 48 hours
Exclusion: History of pneumonia; dissatisfaction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2010-09-20, 1389/06/29
Ethics committee reference number
Under evaluation
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
J15.9
ICD-10 code description
Bacterial pneumonia, unspecified
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
7 days
Method of measurement
Assay with Clinically infectious pulmonary score and bronchoscopy
Secondary outcomes
1
Description
ICU length of stay
Timepoint
during ICU stay
Method of measurement
days that patient is stayed in ICU
Intervention groups
1
Description
All patients in control group will receive enteral capsules of placebo (1 capsule/12h) for one week in addition to standard VAP treatment.
Category
Placebo
2
Description
All patients in intervention group will receive enteral capsules of Lactocare (1 capsule/12h) for one week in addition to standard VAP treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital ICU
Full name of responsible person
Ata Mahmoodpoor
Street address
Shohada hospital, El-goli street
City
Tabriz
2
Recruitment center
Name of recruitment center
General ICU of Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
General ICU, Imam Reza hospital, Golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Farhudi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz 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
Anesthesiology department, Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Director of ICU, Associate Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3332 8009
Fax
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
ICU director, Associate Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3332 8009
Fax
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Roqhiye Asghari
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Anesthesia department office, Faculty of Medicine, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
Dr.asghari80@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)