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Effect of Probiotics on Ventilator Associated Pneumonia in Adult Patients in Intensive Care Unit

Protocol summary

Summary
Objectives: The aim of this study was to investigate the incidence of ventilator associated pneumonia (VAP) in 140, ICU patients with oral preventive probiotics in the treatment group and the placebo in the control group. Research design: A randomized, double-blind, respective study. Inclusion criteria: age of eighteen years and above, the consent of relatives, patients with tracheal intubation and mechanical ventilation which will be continued to the next 72 hours, patients' intubation must not be for more than 48 hours, starting patients' feeding until 24 hours. Exclusion criteria: pregnancy, weakened immune system due to any reason, suppressor of the immune system, replacement heart valves, vascular grafts, heart trauma, history of rheumatic fever, endocarditis, congenital anomaly of heart, injury of stomach, esophagus, bowel, injury to airway, pancreatitis and base skull fracture . Sample Size: 140 patients found eligible based on the inclusion criteria. Interventions: intervention group received probiotics capsule once daily and in the control group, placebo once daily were used. While, Staphylococcus aureus, Pseudomonas and Klebsiella, Acinetobacter were the most common bacteria and the diagnosis of VAP will be based on the culture of sputum culture of BAL. Intervention time: immediately after admission of the qualified patients into the study.

General information

Acronym
VAP(Ventilator Associated Pneumonia
IRCT registration information
IRCT registration number: IRCT2014051417691N1
Registration date: 2014-12-16, 1393/09/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-16, 1393/09/25
Registrant information
Name
Gholamreza Dabiri
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 2698
Email address
dabiri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Probiotics on Ventilator Associated Pneumonia in Adult Patients in Intensive Care Unit
Public title
Effect of Probiotics on Ventilator Associated Pneumonia in Intensive Care Unit
Purpose
Prevention
Inclusion/Exclusion criteria
Including criteria: Age above 18 ; Special concept from first relatives; Endotracheal tube for at least 72 hrs. Exclusion criteria : Pregnancy; Immune-suppression; Prosthetic cardiac valve; Vascular graft ; Cardiac trauma; History of rheumatic fever; Endocarditis; Congenital cardiac abnormality; Gasteroesophagial or intestinal injury; Pancreatitis ; Fracture base skull
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CT-P-9341-4681

Health conditions studied

1

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
During Hospitalization in ICU
Method of measurement
Microbial Culture

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group we used one capsule of probiotic blend: cfu〖10〗^5 ,every day orally for each patient during the hospitalization in the ICU.
Category
Treatment - Drugs

2

Description
In control group one capsule of placebo is used everyday orally for each patient during the hospitalization in the ICU.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajae Hospital
Full name of responsible person
Gholamreza Dabiri
Street address
Rajae Hospital, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
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
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 of Medical Sciences
Full name of responsible person
Gholamreza Dabiri
Position
Anesthesiologist, Intensive Care fellowship
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
Dabiri@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
Mansoor Masjedi
Position
Anesthesiologist, Intensive Care Fellowship
Other areas of specialty/work
Street address
Anesthesiology office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masjedi@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
Gholamreza Dabiri
Position
Anesthesiologist, Intensive Care Fellowship
Other areas of specialty/work
Street address
Anesthesiology office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
Dabiri@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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