Determining the effect of preoperative calcitriol on inflammatory factors after percutaneous nephrolithotomy
Design
A randomized, single-blinded, controlled clinical trial with a parallel groups design of 14 patients using block randomization
Settings and conduct
This study will be conducted in Faghihi hospital, Shiraz. Patients will be divided into two groups (intervention and control). Patients in the intervention groups will receive 2 mcg of intravenous calcitriol two hours before the operation, while patients in the control groups will receive normal saline. Serum inflammatory markers will be recorded both before and 24 hours after the operation. Participants are blinded to the study, but the surgeon knows the contents of the ampules.
Participants/Inclusion and exclusion criteria
Patients above 18 years of age who undergo percutaneous nephrolithotomy will be included. However, patients with use of vitamin D supplements, serum vitamin D of above 100 nmol/L, high serum calcium, use of NSAIDs, previous history of allergic reactions to calcitriol, and metabolic bone diseases will be excluded.
Intervention groups
Intervention group: 2 mcg intravenous calcitriol two hours before the operation
Control group: intravenous normal saline two hours before the operation
Main outcome variables
Serum inflammatory factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230815059154N1
Registration date:2023-08-26, 1402/06/04
Registration timing:registered_while_recruiting
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Abdolreza Haghpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 1087
Email address
rezahaghpanah@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative calcitriol on inflammatory markers following percutaneous nephrolithotomy (PCNL): a randomized controlled trial
Public title
Effect of calcitriol on post-percutaneous nephrolithotomy inflammation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 18 years of age
Patients undergoing percutaneous nephrolithotomy
Exclusion criteria:
Using vitamin D supplements
Serum vitamin D level above 100 nmol/L
High serum calcium level
Using of NSAID drugs
Previous allergic reactions to calcitriol
Having metabolic bone diseases
Not willing to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into placebo groups and the study group in a 1 to 1 ratio and block randomization. This randomization is done by the following website:
https://www.sealedenvelope.com/simple-randomiser/v1/lists
In this type of randomization, which helps to equalize the number of samples in two groups, patients are divided into blocks (for example, 4, 6, or 8 people) in which an equal number of patients from each group are placed in each block. Then, blocks are selected randomly by the above site and randomization is done. Using the site, a list of the order of patients belonging to each group is prepared.
The drug package related to the placebo and the drug is the same, it has no name and the patient cannot distinguish whether it is a placebo or a drug, but the surgeon knows the content of the ampoule and according to the random list prepared, the drug or placebo will be injected to the patient after re-explanation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are blinded to the study. The drug package related to placebo and drug is the same, it does not have a name, and the patient cannot distinguish whether it is a placebo or a drug, but the surgeon knows the contents of the ampule.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, in front of Palestine street, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.SUMS.MED.REC.1402.190
Health conditions studied
1
Description of health condition studied
Kidney stone
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Serum inflammatory factors
Timepoint
Before operation and 24 hours after operation
Method of measurement
Laboratory kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 mcg intravenous calcitriol injection two hours before the operation
Category
Treatment - Drugs
2
Description
Control group: intravenous normal saline injection two hours before the operation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi hospital
Full name of responsible person
Abdolreza Haghpanah
Street address
Shahid Faghihi hospital, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
rezahaghpanah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Central building of Shiraz University of Medical Sciences, in front of Palestine street, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
IR.SUMS.MED.REC.1402.190
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
10
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
Shiraz University of Medical Sciences
Full name of responsible person
Abdolreza Haghpanah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Faghihi hospital, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
rezahaghpanah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abdolreza Haghpanah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Faghihi hospital, Zand Ave,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
rezahaghpanah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abdolreza Haghpanah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Faghihi hospital, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
rezahaghpanah@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
As long as we want to share the result of our study, we will write a paper that contains all the information about our study, such as method, analysis, and results. Also, if the journal or other researchers ask us to share our patients' data and their informed consent, we will be ready to share them.
When the data will become available and for how long
After the paper is published
To whom data/document is available
All the researchers that prove they are researchers
Under which criteria data/document could be used
Researchers can use the data only for their personal use. The data cannot be used for their papers because it causes data duplication.
From where data/document is obtainable
By sending an email to the corresponding author who is Dr. Haghpanah. His email address:
rezahaghpanah@yahoo.com
What processes are involved for a request to access data/document
Researcher who needs our data must introduce his/her completely (including his/her name and family name, occupation, place of work, address) and introduce us two to three of his/her previous studies along with the request email. After the researchers' information is confirmed by the responsible author, the documents will be sent to them as soon as possible after receiving the email. Before sending, the documents or files are checked for the personal information of the patients, and if any part of the information is personal, such as their name and national code, that information is deleted from the documents so that the identity of the patients is not revealed.