Serum sodium variations in hyponatremic patients undergoing hemodialysis with high- and low-flux dialyzers: A randomized controlled trial

Public Title: Serum Natremic Variations in Patients with Hyponatremia on Hemodialysis with High and Low Flux Dialyzers: A Randomized Controlled Trial

Scientific Title: A Prospective, Randomized, Controlled Trial to Evaluate Serum Sodium Variations in Hyponatremic Patients Undergoing Hemodialysis with High-Flux versus Low-Flux Dialyzers

Health Condition / Problem Studied: Hyponatremia in patients with end-stage renal disease (ESRD) or acute kidney injury (AKI) requiring hemodialysis

Study Design: Single-centre, Prospective, Randomized, Parallel-Group, Controlled, Interventional Trial

Study Type: Interventional (Non-drug, Device-based Physiological Study)

Phase: Not Applicable (Non-drug study)

Intervention / Comparator Arms:

Arm A (Intervention): High-flux hemodialysis using approved high-flux dialyzer membrane

Arm B (Comparator): Low-flux hemodialysis using approved low-flux dialyzer membranes

Primary Outcome Measure:

Mean change in serum sodium concentration (mEq/L) from pre- to post-dialysis between high-flux and low-flux groups

Secondary Outcome Measures:

Comparison of 30-day mortality between groups

Change in Mini-Mental State Examination (MMSE) scores pre- and post-dialysis to assess neurocognitive impact

Inclusion Criteria:

**1.**Adult patients (>18 years) requiring hemodialysis with serum sodium 115–135 mEq/L

2.Voluntary written informed consent

Exclusion Criteria:

**1.**Shock (SBP <100 mmHg)

2.Pregnancy

3.Patients not consenting to participation

4.Those requiring CRRT, CAPD, or SLED

5.Chronic liver disease

Sample Size: 80 patients (40 per group)

Randomization: Computer-generated random sequence with allocation concealment

Study Duration: Total duration: 12 months Individual participant follow-up: 30 days Study period: May 2025 – December 2026

Study Site: Department of Nephrology, Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) & Dr. Ram Manohar Lohia Hospital, New Delhi, India

Principal Investigator: Dr. Anubhav Chakraborty, Senior Resident, Department of Nephrology, ABVIMS & Dr. RML Hospital, New Delhi Email: anubhavchakraborty1@gmail.com  Contact: +91-7666192795

Supervisor / Guide: Dir. Prof. (Dr.) Himansu Sekhar Mahapatra, Director Professor & Head, Department of Nephrology, ABVIMS & Dr. RML Hospital, New Delhi

Ethics Approval: Approved by Institutional Review Board / Institutional Ethics Committee, ABVIMS & Dr. RML Hospital, New Delhi

Funding Source: Institutional (No external or industry sponsorship)

Estimated Date of First Enrollment: may 1 , 2025

Estimated Date of Study Completion: December 31, 2026