Comparison of two types of persistent catheter (Foley catheter with LoPro urinary catheter) in the prevention of catheter-related urinary tract infections in patients in the intensive care unit
Design
Clinical trials with control and intervention group, with parallel groups, blind, randomized
Settings and conduct
The study is carried out at the of Besat Hospital in Hamedan, and patients entering the study are enrolled in the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria;
1-Decreased consciousness (GCS less than 9 )
2-Normal body temperature (axillary =35.5-37%)
3-The doctor's order for urinary catheterization
4-Not having a urinary tract infection or bacteriuria prior to admission
5-Not having underlying diseases such as diabetes, CKD, nephrosclerosis, acute or chronic glomerulonephritis, and pyelonephritis
6-Not having immune deficiency disorders such as lupus erythematosus, rheumatoid arthritis, MS
7-Not having trauma and rupture of the urethra and bladder
8-Not getting aminoglycoside medications
9-Age over 18 years
Exclusion Criteria:
1-Exit the catheter for any reason (exits by patient or on doctor's instructions) before 3 days
2-Death or transmission of the patient before the completion of the study
Intervention groups
Patients admitted to the intensive care unit who have a Foley catheter
Main outcome variables
ESR-Leukocytosis-Type of germ - The number of germs
General information
Reason for update
Acronym
پیشگیری
IRCT registration information
IRCT registration number:IRCT20100816004578N7
Registration date:2019-03-14, 1397/12/23
Registration timing:prospective
Last update:2019-03-14, 1397/12/23
Update count:0
Registration date
2019-03-14, 1397/12/23
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two types of indwelling catheter in prevention catheter-associated urinary tract infections in ICU patients
Public title
Impact of two types of indwelling catheter in prevention catheter-associated urinary tract infectionson
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Decreased consciousness (less than 9 in GCS)
Normal body temperature (as axillary 35.5-37%)
The doctor's order for urinary catheterization
Not having a urinary tract infection or bacteriuria prior to admission
Not having underlying diseases such as diabetes, CKD, nephrosclerosis, acute or chronic glomerulonephritis, and pyelonephritis
Not having immune deficiency disorders such as lupus erythematosus, rheumatoid arthritis, MS
Not having trauma and rupture of the urethra and bladder
Not getting aminoglycoside medications
Age over 18 years
Exclusion criteria:
Exit the catheter for any reason (exits by patient or on doctor's instructions) before 3 days
Death or transmission of the patient before the completion of the study
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
All patients with entry criteria will be identified. Then, the allocation of patients to the Foley catheter group or the LoPro urinary catheter will be randomized. The computer generated randomization list is first generated and the randomly assigned duplicate blocks (1: 1) are printed on paper and packed in envelopes. Each envelope will be opened after receiving written consent from the patient's ward.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since patients with a decreased level of consciousness, blind blindness is not conceptualized. The laboratory warden will not be aware of the groups being studied. Also, since the difference is only in the physical structure of the bladder end of the catheter and the visible parts in the two types of catheter are similar, therefore, nurses working in the ICU will not be aware of the type of catheter used for the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamedan
Province
Hamadan
Postal code
6514845411
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.UMSHA.REC.1397.766
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
N30.2
ICD-10 code description
Other chronic cystitis
Primary outcomes
1
Description
Number Bacteria
Timepoint
Before and After 1،2،3 days
Method of measurement
Urine Culture
2
Description
Type of Bacteria
Timepoint
Before and After 1،2،3 days
Method of measurement
Urine Culture
Secondary outcomes
1
Description
ESR
Timepoint
Before and After 3 days
Method of measurement
Vstrgryn
2
Description
Leukocytosis
Timepoint
Before and After 3 days
Method of measurement
Cell Blood Count
3
Description
Nitrite
Timepoint
Before and After 1.2.3 days
Method of measurement
Urinalysis
4
Description
Body temperature
Timepoint
Before and After 1.2.3 days
Method of measurement
Axillary with medical thermometer
5
Description
pH of the urine
Timepoint
Before and After 1.2.3 days
Method of measurement
DIP STICK
6
Description
The color of the urine
Timepoint
Before and After 1.2.3 days
Method of measurement
DIP STICK
Intervention groups
1
Description
Intervention group: In this group of a type of catheter with oval holes on both sides, the LoPro (Low Profile) catheter is a short and an end tip slightly higher than the balloon loop
Category
Prevention
2
Description
Control group:Use Foley Root Catheter in section
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Farshid Rahimi Bashar
Street address
General ICU, BESAT Hospital, Motahhari boulevar, Resalat Square
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0025
Email
f.rahimi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0025
Email
f.rahimi@umsha.ac.ir
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 and Technology of Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0025
Email
frahimi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square
City
Hamedan
Province
Hamadan
Postal code
65148454411
Phone
+98 81 3264 0025
Email
f.rahimi@umsh.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farahnaz Ramezani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0025
Email
ramezanifarah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
All the studied demographic and clinical characteristics will be issued.
When the data will become available and for how long
The study protocol will be issued in the article.
To whom data/document is available
After publishing the results, the data will be provided to the requesting users.
Under which criteria data/document could be used
The data will be available for use in the systematic review and meta-analysis studies.
From where data/document is obtainable
Dr. Mahnaz Kitaban and Mrs. Farahnaz Ramezani (Project executives)
What processes are involved for a request to access data/document
By sending an email request to the project executives.