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IRCT20230824059250N1 IRCT 2023-08-30 Ahvaz University of Medical Sciences The effect of low sodium level of dialysis fluid on cardiac function of chronic hemodialysis patients Evaluation of the cardiac function in chronic hemodialysis patients with low sodium levels in the dialysis fluid 2023-09-23 anticipated 80 Complete https://irct.ir/trial/72238 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with eligibility criteria will be divided into two groups using a randomized block design. An online website (https://www.sealedenvelope.com) generates a random list based on the desired sample size and block size of 4. After creating a list, each patient will be identified with a unique code throughout the study. 40 people are selected for the first intervention group and 40 for the second intervention group. While the patients and the therapist do not know the amount of sodium received, Blinding description: The participant, the researcher, and the treatment staff are kept blind, and sodium dialysis liquid is adjusted by a nurse not related to the research. N/A Chronic hemodialysis. Intervention 1: Intervention group: Dialysis liquid sodium, 135 hemodialysis three to four times a week for three months. Intervention 2: Intervention group: Sodium dialysis fluid, 140 hemodialysis three to four times a week for three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Masud Rahmani
Farvardin Street, Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6441945781 +98 61 3314 0000 rahmani.ma@ajums.ac.ir Ahvaz University of Medical Sciences scientific Masud Rahmani
Farvardin Street, Golestan Hospital
Ahvaz Iran (Islamic Republic of) 6441945781 +98 61 3314 0000 rahmani.ma@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adults undergoing chronic hemodialysis 18 years 60 years Both Age less than 18, age more than 60 Uncontrolled underlying disease Presence of active infection Sodium acetate less than 130 Low blood pressure Muscle cramps I95.3 Hypotension of hemodialysis Treatment - Other Treatment - Other Intervention group: Dialysis liquid sodium, 135 hemodialysis three to four times a week for three months Intervention group: Sodium dialysis fluid, 140 hemodialysis three to four times a week for three months Blood pressure. Timepoint: The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention. Method of measurement: Mercury sphygmomanometer. Muscle cramps. Timepoint: The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention. Method of measurement: History and physical examination. Efficacy of blood pressure lowering drugs used by the patient. Timepoint: The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention. Method of measurement: Sphygmomanometer and history. Weight. Timepoint: The beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the intervention. Method of measurement: scale. Ahvaz University of Medical Sciences Approved 2023-05-27 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Farvardin Street, Golestan Hospital Ahvaz Khouzestan Iran (Islamic Republic of)