The aim of this randomized double blind clinical trial, the evaluation of efficacy of probiotic in prevention of ventilator associated pneumonitis in 164 patient admitted in ICU of rouhani hospital of Babol.
Inclusion criteria: written consent from the family member; continuance of mechanical ventilation at least 72 hours; maximum 48 hours from intubation; start nutrition after 48 hours; no pneumonia; no tracheostomy
Exclusion criteria: pregnancy; replacement of heart valve; vascular graft; history of rheumatoid fever; endocarditis; pancreatitis; fracture of base of skull; discharge less than one week.
Intervention: Intervention group: the consumption of familact with the dose of 500 mg twice a day for 10 days. Control group: the consumption of placebo with the dose of 500 mg twice a day for 10 days.
Patients are monitored for up to two weeks during mechanical ventilation and the incidence of pneumonia caused by mechanical ventilation is measured by a clinical evaluation of pulmonary infection that is measured every three days. In case of pneumonia the diagnosis was confirmed according to clinical pulmonary infection score. Primary outcome: prevention of ventilation associated pneumonitis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707227752N10
Registration date:2017-08-04, 1396/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-04, 1396/05/13
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Babol University Of Medical Sciences
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic on prevention of ventilator associated pneumonia in the patients admitted to ICU
Public title
The effect of probiotic on prevention of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: written consent from the family member; continuance of mechanical ventilation at least 72 hours; maximum 48 hours from intubation; start nutrition after 48 hours; no pneumonia; no tracheostomy
Exclusion criteria: pregnancy; replacement of heart valve; vascular graft; history of rheumatoid fever; endocarditis; pancreatitis; fracture of base of skull; discharge less than one week.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The Patients are divided to a case and a control group according to Table of Random Numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Rouhani hospital, Ganjafrouz Street
City
Babol
Postal code
47176-41367
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
MUBABOL.REC.1395.198
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J18
ICD-10 code description
Pneumonia, organism unspecified
Primary outcomes
1
Description
Ventilator associated pneumonia
Timepoint
3 days after intervention
Method of measurement
CPIS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the consumption of familact with the dose of 500 mg twice a day.
Category
Prevention
2
Description
Control group: the consumption of placebo the the dose of 500 mg twice a days for 10 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Mehdi Nasouhi
Street address
Rouhani Hospital, Ganjafrooz Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor research for Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Babol University Of Medical Sciences, Ganjafrooz street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor research for Babol 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
Babol University of Medical Sciences
Full name of responsible person
Parviz Amrimaleh
Position
Associated Professor of Anesthesiology
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
pamrimaleh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Mahmoud Monadi
Position
Assistant Professor of Internal Department
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
dr.monadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Mahmoud Monadi
Position
Assistant Professor of Internal Department
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
dr.monadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)