Determining the effect of gavage of cranberry on the prevention of catheter-dependent urinary tract infections in patients admitted to the intensive care unit
Design
A randomized clinical trial with a control group, with two parallel groups
Settings and conduct
This study is a randomized clinical trial will be done on two groups of 100 patients who have a foley catheter that admitted to the intensive care units of Besat hospital in Hamedan . Before the intervention, patients will be randomly divided into two groups:intervention and control. Before the intervention, urine culture and complete blood cell counting(CBC) will be checked . In the intervention group, in addition to routine care from the foley catheter, a Cranberry tablet (500 mg) will be used twice a day for four days. On the fifth day, tests of urine culture and blood count of patients will be measured again. In the control group only routine care will be taken from the catheter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients should have urinary catheters,do not having urinary tract infection before the study, do not rupture urinary tract and bladder damage.
Exclusion criteria: Exit the urethral catheter for any reason before the end of the study period, cranberry sensitivity
Intervention groups
Intervention: In the intervention group, in addition to rutine care from the Foley catheter , the cranberry tablet(500mg) will be given twice a day at 9 o'clock and 5 o'clock by gavage.
Control group: Control group will receive only routine care from the catheter foley .
Main outcome variables
Urinary infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N24
Registration date:2019-07-10, 1398/04/19
Registration timing:prospective
Last update:2019-07-10, 1398/04/19
Update count:0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cranberry gavage on prevention catheter related urinary tract infection in hospitalized patients at intensive care unit
Public title
The effect of cranberry gavage on prevention catheter related urinary tract infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should have urinary catheters
Do not have urinary tract infection before the study
Do not have rupture urinary tract and bladder damage
Age over 18 years
Exclusion criteria:
Exit the urethral catheter for any reason before the end of the study period
Having sensitivity to cranberry
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using 2-point permutational block method and randomization was done by computer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics زommittee of Hamadan university of medical sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.UMSHA.REC.1398.148
Health conditions studied
1
Description of health condition studied
Urinary tracr infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Urinary infection
Timepoint
Before and 5 days after the intervention
Method of measurement
urine culture tests and complete blood count(CBC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to rutine care from the Foley catheter , the cranberry tablet(500mg) will be given twice a day by gavage.
Category
Prevention
2
Description
Control group: Control group will receive only routine care from the catheter foley( Washing the perineal area).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Aziz azizi
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0150
Email
a.azizi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeei Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0150
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Azim Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.azizi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.azizi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vahideh Maarefian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
vahideh.maarefian@gmail.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