Investigate the role of early removing of the catheter in renal transplant patients on the reduction of urinary tract infections
Design
In this interventional study, a total of 88 consenting patients will be selected and divided in two groups using block randomization method (n=44 in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen.
Settings and conduct
The patients will be divided into two groups randomly. The first group: urethral Catheter will be removed after 3 days of post kidney transplantation operation, and in second group: urethral catheter will be removed 7days after post kidney transplantation. In all of patients two urine samples will be provided for analysis and culture. One sample at time of removing urethral catheter and second sample at 7 days’ post removal of urethral catheter. Patients' blood pressure also will be measured at the time of sampling for urinary culture and the results will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of kidneys recipient; negative urinary culture; three medications including Tacrolimus, prednisolone and Cellcept; operation by the same team of surgery. Exclusion criteria: Unwillingness of the patient to continue cooperation in the plan; patient with history of lower urinary tract disease; abnormality of lower urinary tract.
Intervention groups
In the first group urethral Catheter will be removed after 3 days of post kidney transplantation operation. In second group urethral catheter will be removed 7 days after post kidney transplantation
Main outcome variables
Urinary tract infections and Blood pressure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150808023559N14
Registration date:2017-12-31, 1396/10/10
Registration timing:prospective
Last update:2017-12-31, 1396/10/10
Update count:0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology,Tabriz university of Medical Sciences
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early Catheter removing effect on the reduced Rate of Urinary Tract Infection in Renal Transplant recipients of Tabriz Imam Reza Hospital
Public title
Early removal of foley cather on infection of recipient post renal transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of kidneys recipient;
negative urinary culture
three medications including Tacrolimus, prednisolone and Cellcept
Exclusion criteria:
Unwillingness of the patient to continue cooperation in the plan
patient with history of lower urinary tract disease
abnormality of lower urinary tract
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method
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 Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2017-04-12, 1396/01/23
Ethics committee reference number
IR.Tbzmed.rec.1396.226
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
T83.5
ICD-10 code description
Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
Primary outcomes
1
Description
Urine caiture
Timepoint
Once upon removal of the catheter and another 7 days’ post removal of urethral catheter
Method of measurement
Use of culture media in the laboratory
Secondary outcomes
1
Description
Blood pressure
Timepoint
Once upon removal of the catheter and another 7 days’ post removal of urethral catheter
Method of measurement
Manual blood pressure monitor
Intervention groups
1
Description
The first group: urethral Catheter will be removed after 3 days of post kidney transplantation operation
Category
Treatment - Surgery
2
Description
second group: urethral catheter will be removed 7 days after post kidney transplantation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kidney transplant ward, Imam Reza Hospital Tabriz
Full name of responsible person
Amin Bageri
Street address
Department of Urology, Imam Reza Hospital, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Email
smr_mtn@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Joiban
Street address
Vice Chancellor for Research and Technology, University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem joiban
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vice Chancellor for Research and Technology, University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
Email
ajouyban@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Afshar Zomorrodi
Position
Professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Department of Urology, Imam Reza Hospital, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3555 3407
Fax
Email
dr_afshar@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amin Bagheri
Position
Resident of Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Department of Urology, Imam Reza Hospital, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3555 3407
Fax
Email
smr_mtn@yahoo.com
Web page address
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
Not applicable
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