Comparison of the effects of potassium citrate and hydrochlorothiazide on the stone formation rate of ureteral stent in patients with prolonged stent insitue in Imam Khomeini Hospital urmia
ٍEvaluation of potassium citrate and hydrochlorothiazide effect on stone formation rate of ureteral stent in patients who needs ureteral stent for long time
Design
A randomized controlled clinical trial, double-blind, with parallel groups, on 130 patients
Settings and conduct
after approval by the University Ethics and Research Committee, 130 patients who will require open or closed urologic surgery which needs ureteral stent be insitu for at least 4 weeks After obtaining informed consent will be included in our study, two equal groups of patients will be entered in our study. group 1 will be patients whith even chart number (control group) and group 2 intervention group with Odd chart number which receive hydrochlorothiazide and potassium citrate but the other group will not receive any medication.The researcher will not be aware of the groups receiving the drugs. All stents will be in same brand and the maximum instu duration for 6 weeks
Participants/Inclusion and exclusion criteria
1.Patients who have 18-65 years old under went urologic surgeries which needs ureteral stent insitu for 4weeks
2.absence of urinary tract infection
3. Absence of metabolic abnormality such as primary or secondary hyperparathyroidism,
4.absence of Ca and Vitamin D supplements usages
Intervention groups
In intervention group Hydrochlorthiazide 50mg PO Daily and one teaspoon of Citratpotassium powder inside the glass of water, three times a day after meal beside the usual post-operation drugs such as acetaminophen and ciprofloxacin will be given, but in control group only acetaminophen and ciprofloxacin will be given
Main outcome variables
Stent Encrustion , duration of stent insitu
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N3
Registration date:2020-04-19, 1399/01/31
Registration timing:registered_while_recruiting
Last update:2020-04-19, 1399/01/31
Update count:0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of potassium citrate and hydrochlorothiazide on the stone formation rate of ureteral stent in patients with prolonged stent insitue in Imam Khomeini Hospital urmia
Public title
Comparison of the effects of potassium citrate and hydrochlorothiazide on the stone formation rate of ureteral stent in patients with prolonged stent insitue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have 18-65 years old under went urologic surgeries which needs ureteral stent insitu for 4weeks
absence of urinary tract infection
Absence of metabolic abnormality such as primary or secondary hyperparathyroidism,
absence of Ca and Vitamin D supplements usages
Exclusion criteria:
Patient age less than 18 or more than 60
stent placement for less than 4 weeks
urinary tract infection
metabolic abnormality such as primary or secondary hyperparathyroidism,
Ca and Vitamin D supplements usages
patients who do not have intend to use Drugs that are prescribed for Stone formation prevention
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and our analyzer team will be blinded about the patients whom received citratpoatassium and hydrochlorthiazide , patients will be allocated to drug or control group according to chart number, patients with even chart number in control group and patients with odds chart number in intervention group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committe of Urmia University of medical Sciences
Street address
Ershad Ave.,Urmia,West Azarbaijan,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
ir.umsu.rec.1396.130
Health conditions studied
1
Description of health condition studied
ureteral stent complication :stent encrustation
ICD-10 code
T83.192A
ICD-10 code description
Other mechanical complication of urinary stent, initial encounter
Primary outcomes
1
Description
Stent Encrustation
Timepoint
4 weeks after ureteral stent insertion
Method of measurement
observation of ureteral stent encrustation during stent extraction with difficult stent extraction due to stent encrustation
Secondary outcomes
1
Description
stent insitu duration
Timepoint
End of intervention ,at the time of stent extraction
Method of measurement
By reviewing the date of surgery and stent insertion from the summary chart at the time of referring to stent extraction
Intervention groups
1
Description
Intervention group:to patients undergoing urologic surgeries which are needed ureteral stent instu for 4 weeks , One Teaspoon potassium citrate powder inside the glass of water three times a day after meal with Hydrochlorothiazide 50 mg daily were prescribed
Category
Treatment - Drugs
2
Description
Control group: patients undergoing urologic surgeries which are needed ureteral stent instu for 4 weeks that usually do not receive any drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital Urmia
Full name of responsible person
Hadi Ranjbar
Street address
Imam Hospital , Ershad Ave., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3345 7287
Fax
+98 44 3223 9648
Email
hadiranjbar7011@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Setad Olumpezeshki Urmia, Reasalat Ave., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4896
Fax
+98 44 3223 4897
Email
Mohebbi_Iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Hospital , Ershad Ave.,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
009833457286
Email
samanf63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assitant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Hospital , Ershad Ave.,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
009833457286
Email
samanf63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Hospital , Ershad Ave.,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
009833457286
Email
samanf63@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Any information without the need for patients' names will be available
When the data will become available and for how long
6 months after publication in journals
To whom data/document is available
medical faculty members
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
samanf63@gmail.com
farshid.s@umsu.ac.ir
What processes are involved for a request to access data/document