Effect of probiotic prophylaxis on the prevention of ventilator associated pneumonia ( VAP ) in ICU patients
Design
A clinical trial with a control group with parallel and two-way blind groups, randomized by systematic random sampling method in such a way that an alphabetically sorted list of patients admitted to the intensive care unit . The determination of intervention and control groups will be based on the last digit of the patient's admission code ; Phase 3 on 134 patients .
Settings and conduct
Patients under mechanical ventilation and hospitalized in the General ICU of Masih Daneshvari Hospital. The examining doctor, the nurse prescribing medicine and placebo, the doctor recording vital signs do not know about the control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients over 18 years of age and intubated under mechanical ventilation in the intensive care unit. Exclusion criteria include the patient's diagnosis of VAP upon arrival; pregnancy ; prosthetic heart valve ; prosthetic vascular graft; immunosuppression ; history of rheumatic fever ; history of gastrointestinal damage in the current admission ; tracheostomy; unwillingness of the patient or his parents ; Intolerance of gavage .
Intervention groups
The intervention group will be prescribed probiotic capsule by gavage and will also receive other standard treatments. The control group will receive standard treatments along with placebo capsules . Standard treatments to prevent VAP include position of the upper body at an angle of 30 degrees ; oral hygiene with chlorhexidine mouthwash ; interruption of sedation during daily periods and waking up the patient ; daily periods of spontaneous breathing .
Main outcome variables
Ventilator associated pneumonia; Length of stay in ICU; Length of antibiotic therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230611058449N1
Registration date:2023-06-27, 1402/04/06
Registration timing:registered_while_recruiting
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Ali Nazembokaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2267 1195
Email address
ali_nb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-19, 1402/03/29
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic prophylaxis on the prevention of ventilator-associated pneumonia (VAP) in patients admitted to the intensive care unit (ICU)
Public title
Effect of probiotic prophylaxis on ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over the age of 18 that are intubated in the intensive care unit
Exclusion criteria:
Diagnosis was ventilator-associated pneumonia from beginning
Diagnosis was pneumonia from beginning
Pregnancy
Prosthetic heart valves
Prosthetic vascular grafts
Immunosuppress
History of rheumatic fever
History of gastrointestinal tract injury in the current hospitalization
Having tracheostomy
Lack of consent of the patient or her or his parents
Gavage intolerance
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study will be systematic random sampling .For each patient in the first group, we will have one patient in the second group. The determination of the people of the first and second groups will be based on the last digit of the patient's admission code. In this way, the first patient whose last digit of their code is odd is placed in the intervention group, and vice versa, the first patient whose last digit of their code is even is placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know which group is the study or the control group, the control group will receive standard treatments along with placebo capsules that look similar to the original capsules produced by Tekgen Biot. The number of drugs, the nurse who prescribes the drug, the examining doctor and the doctor who registers the vital signs do not know about the patient group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in medical school research
Street address
Sixth floor ; 2nd Building ; Shahid Beheshti University of Medical Sciences ; Arabi street ; Yemen Street ; Shahid Chamran Highway ; Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-05-27, 1402/03/06
Ethics committee reference number
IR.SBMU.MSP.REC.1402.096
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Clinical Pulmonary Infection Score
Timepoint
Clinical Pulmonary Infection Score at the beginning of the study and the third day after probiotic consumption.
Method of measurement
Clinical Pulmonary Infection Score using ; body temperature ; leukocyte count and morphology , tracheal secretion volume and character , PaO2/FiO2 values , presence of pulmonary infiltration ; Tracheal aspirate culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients over 18 years of age and intubated with mechanical ventilation randomly placed in the intervention group of this study will use BioIBS probiotic capsules produced by Tekgen Biot Company, each capsule containing 5 x 10 to the power of 9 Lactobacillus Casei, Lactobacillus Rhamnosus, Lactobacillus Acidophilus . The prescribed dosage of probiotics will be one capsule every 12 hours for 15 days. They will also receive other standard treatments to prevent ventilator-associated pneumonia , which include position of the head and upper body at an angle of 30 degrees; Oral hygiene of the patient with chlorhexidine mouthwash; Cessation of sedation during daily periods and waking the patient up; Daily periods of spontaneous breathing of the patient.
Category
Treatment - Drugs
2
Description
Control group: Patients over 18 years of age and intubated and connected to mechanical ventilation were randomly placed in the control group of this study and will receive standard treatments along with placebo capsules that look similar to the original capsules produced by Tekgen Biot. Standard treatments to prevent They will also receive ventilator-related lung infection, which include: position of the head and upper body at an angle of 30 degrees, oral hygiene of the patient with chlorhexidine mouthwash, interruption of sedation during daily periods and waking up the patient, daily periods of spontaneous breathing of the patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Ali Nazembokaee
Street address
Darabad ; Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
ali_nb@Yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Darabad ; Shahid Bahonar Street (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
ali_nb@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazembokaee
Position
Fellow Assistant of Critical Care Medicine
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad ; Shahid Bahonar Street
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
ali_nb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazembokaee
Position
Fellow Assistant of Critical Care Medicine
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad ; Shahid Bahonar Street
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
ali_nb@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazembokaee
Position
Fellow Assistant of Critical Care Medicine
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad ; Shahid Bahonar Street
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
ali_nb@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available