The effect of potassium citrate administration on type of stone on ureteral stents compared with primary stone
Design
Clinical trial with two parallel groups without blinding, simple randomization
Settings and conduct
This clinical trial will be performed in Sina Hospital. Patients will be divided into control and intervention groups by simple randomization method.One group was treated with potassium citrate daily and the other group was not treated.
The stones removed by the laboratory are checked for material.
The DJ stent is also checked for leaks and stones after leaving.
The difference between the material and the composition of the stone and the castration on the stent is also investigated in people who consume potassium citrate with people who do not consume potassium citrate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all people who had a Stent Dj after having kidney stones treated.
Exclusion criteria: the stone is not formed on the Dj; people who don't want to leave Dj; the stone is not formed on the Dj.
Intervention groups
One group was treated with potassium citrate daily
and the other group was not treated.
Main outcome variables
How long does a DJ stent last?
Combining the patient's primary stone
The composition of the stone formed on the Dj stent is due to the presence of citrate and the absence of citrate
Number of doses of potassium citrate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N6
Registration date:2020-06-20, 1399/03/31
Registration timing:registered_while_recruiting
Last update:2020-06-20, 1399/03/31
Update count:0
Registration date
2020-06-20, 1399/03/31
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of potassium citrate administration on type of stone on ureteral stents compared with primary stone
Public title
The therapeutic effect of potassium citrate on the type of stone formed on ureteral stents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people who had a Stent Dj after having kidney stones treated
Exclusion criteria:
People who don't have a DJ.
People who don't want to install a DJ.
The stone is not formed on the Dj.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
In block randomization, patients are divided into two groups.
One group was treated with potassium citrate daily and the other group was not treated.
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 Committees in Medical Medical Research
Street address
Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.TUMS.VCR.REC.1398.902
Health conditions studied
1
Description of health condition studied
Urinary stones
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
The composition of the stone formed on the Di stent is due to the presence of citrate and the absence of citrate.
Timepoint
Immediately after leaving Dj
Method of measurement
Pathology and Stone Detection Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, after the stone operation and the installation of a DJ, they were treated with potassium citrate 30 mg daily.
Category
Treatment - Drugs
2
Description
Control group: In this group, they did not receive potassium citrate after the stone operation and the installation of a DJ.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Hassan Abad
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran. Keshavarz Boulevard, Quds Ave., Central University, Sixth Floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Aghamir
Position
Head of urology researchc center department
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Hassan Abad Asqu. Sina Hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8560
Email
mkaghamir@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Re-information for the purpose of clarification Using data by referring to the article's original Get permission from the author of the article and the presenter
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.