Comparison of the effect of low and normal levels of sodium in the dialysis fluid on the levels of calcium, phosphorus and parathyroid hormone in patients undergoing chronic hemodialysis
Determining the effect of sodium in the dialysis fluid on the level of calcium, phosphorus and parathyroid hormone in chronic hemodialysis patients
Design
A double-blind randomized controlled clinical trial will be conducted on 80 patients undergoing chronic hemodialysis.
Settings and conduct
In this randomized controlled clinical trial study, 80 chronic hemodialysis patients referring to the dialysis center of Ahvaz Golestan Hospital will be included after considering the inclusion and exclusion criteria. The number of each patient will be placed on the medication envelope based on the randomization list of the software. The sodium solutions will be packaged in such a way that the patient will not know the amount of sodium in the dialysis solution and will be performed by a nurse unrelated to the research so that the project manager will not know about it. Then, a group of 40 people will be treated with hemodialysis with liquid sodium 140 and another group will be treated with liquid sodium 135 milliequivalent/liter. Before the start of hemodialysis, then 1 month and 3 months after the start of dialysis, serum calcium, phosphorus and hormones The patient's parathyroid will be checked and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: chronic hemodialysis patients aged 18 to 60 years
Exclusion criteria: the presence of any uncontrolled background disease, presence of active infection, drop in systolic or diastolic blood pressure more than 20 mmHg compared to the patient's baseline pressure, the occurrence of frequent muscle cramps that cannot be found in the investigation of the cause other than low sodium. The patient's sodium is less than 130 mEq/L.
Intervention groups
Patients will be randomly divided into two groups receiving sodium 135 and 140 mEq/L
Main outcome variables
Calcium, phosphorus and parathyroid hormone levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231217060445N1
Registration date:2023-12-30, 1402/10/09
Registration timing:prospective
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Ladan Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 4501
Email address
dr.l.mirzaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low and normal levels of sodium in the dialysis fluid on the levels of calcium, phosphorus and parathyroid hormone in patients undergoing chronic hemodialysis
Public title
Determining the effect of sodium levels of dialysis fluid on the levels of calcium, phosphorus and parathyroid hormone in patients undergoing chronic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic hemodialysis patients aged 18 to 60 years
Exclusion criteria:
The presence of any uncontrolled underlying disease (such as pheochromocytoma or other cardio-pulmonary and liver diseases)
Presence of active infection
Occurrence of frequent muscle cramps that cannot be found due to low sodium.
Patient's sodium is less than 130 mEq/L
Systolic or diastolic blood pressure drop of more than 20 mm Hg compared to the patient's baseline pressure.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using a calculator, random numbers from 1 to 80 were generated. 40 numbers and the first number produced by the calculator were assigned to the intervention group and the next 40 numbers to the control group, then the packet of soluble sodium was given to the researcher in order from 1 to 40 to prescribe to the nurse.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sodium solution will be in similar packages. The number of each patient will be placed on the medication envelope based on the randomization list of the software. Only the nurse will be aware of the number assigned to the relevant group. Then, from 1 to 80, the sodium solution will be available to the nurse to administer to the patients. The patient will not know the amount of sodium used in the dialysis solution and it will be done by a nurse not related to the research, so the performing doctor will not know about it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan town, Golestan Blvd, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-12-02, 1402/09/11
Ethics committee reference number
IR.AJUMS.REC.1402.470
Health conditions studied
1
Description of health condition studied
Patients undergoing chronic hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
calcium
Timepoint
Before starting the study, one and three months after dialysis
Method of measurement
blood test
2
Description
phosphorus
Timepoint
Before starting the study, one and three months after dialysis
Method of measurement
Blood test
3
Description
Parathyroid hormone
Timepoint
Before starting the study, one and three months after dialysis
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: the group that will undergo hemodialysis with a sodium solution of 135 mEq/L.
Category
Treatment - Drugs
2
Description
Control group: the group that will undergo hemodialysis with sodium solution of 140 mEq/L.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Ladan Mirzaei
Street address
Golestan Ave, Golestan Hospital, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8328
Email
dr.l.mirzaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zakerkish
Street address
Golestan Town, Golestan Blvd., Research and Technology Development Vice-Chancellor. Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3337 8628
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ladan Mirzaei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Ave., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3337 8628
Email
dr.l.mirzaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asieh Aref
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Golestan Ave., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3337 8268
Email
aref-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ladan Mirzaei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan St., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8628
Email
dr.l.mirzaei@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
Information about the main outcome or similar can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
No
Under which criteria data/document could be used
No
From where data/document is obtainable
Dr. Ladan Mirzaei
What processes are involved for a request to access data/document