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IRCT20231217060445N1 IRCT 2023-12-30 Ahvaz University of Medical Sciences Determining the effect of sodium levels of dialysis fluid on the levels of calcium, phosphorus and parathyroid hormone in patients undergoing chronic hemodialysis 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 2024-01-21 anticipated 80 Complete https://irct.ir/trial/74673 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Patients undergoing chronic hemodialysis. Intervention 1: Intervention group: Intervention group: the group that will undergo hemodialysis with a sodium solution of 135 mEq/L. Intervention 2: Control group: the group that will undergo hemodialysis with sodium solution of 140 mEq/L. Yes - There is a plan to make this available What will be shared: Information about the main outcome or similar can be shared. When: The access period starts 6 months after the results are published To whom: No Conditions: No Where to obtain: Dr. Ladan Mirzaei How to obtain: Communicate with the responsible person Comments:
public Ladan Mirzaei
Golestan Ave., Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3337 8628 dr.l.mirzaei@gmail.com Ahvaz University of Medical Sciences scientific Asieh Aref
Golestan Ave., Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3337 8268 aref-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Chronic hemodialysis patients aged 18 to 60 years 18 years 60 years Both 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. Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: the group that will undergo hemodialysis with a sodium solution of 135 mEq/L. Control group: the group that will undergo hemodialysis with sodium solution of 140 mEq/L. Calcium. Timepoint: Before starting the study, one and three months after dialysis. Method of measurement: blood test. Phosphorus. Timepoint: Before starting the study, one and three months after dialysis. Method of measurement: Blood test. Parathyroid hormone. Timepoint: Before starting the study, one and three months after dialysis. Method of measurement: Blood test. Ahvaz University of Medical Sciences Approved 2023-12-02 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Golestan town, Golestan Blvd, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)