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CTRI Number  CTRI/2025/12/099731 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Sodium Balance in Hemodialysis: High-Flux vs. Low-Flux Dialyzers in Patients with sodium levels 
Scientific Title of Study   Serum sodium variations in hyponatremic patients undergoing hemodialysis with high- and low-flux dialyzers: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anubhav Chakraborty 
Designation  Senior resident ,nephrology 
Affiliation  ABVIMS and Dr RML Hospital , New Delhi 
Address  B 1410, New Doctors Hostel , RMLH New Delhi 110001

New Delhi
DELHI
110001
India 
Phone  7666192795  
Fax    
Email  anubhavchakraborty1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Himansu Sekhar Mahapatra 
Designation  Head of the Department , Department of Nephrology 
Affiliation  ABVIMS and Dr RML Hospital , New Delhi 
Address  room no 307 , PGI building , ABVIMS and RML hospital , new delhi

New Delhi
DELHI
110001
India 
Phone  9968474805  
Fax    
Email  hsmnephro@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anubhav Chakraborty 
Designation  Senior resident ,nephrology 
Affiliation  ABVIMS AND Dr RML Hospital; , New Delhi 
Address  B 1410, New doctors hostel , rml hospital

New Delhi
DELHI
110001
India 
Phone  7666192795  
Fax    
Email  anubhavchakraborty1@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr RML hospital , New Delhi  
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital 
Address  ABVIMS and Dr Rml Hospital , Baba Kharak Singh Marg, near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ANUBHAV CHAKRABORTY  ABVIMS AND DR RML HOSPITAL  B 1410, NEW DOCTORS HOSTEL , RML HOSPITAL BABA KHARAK SINGH MAARG
New Delhi
DELHI 		 7666192795

anubhavchakraborty1@gmail.com 
Dr Anubhav Chakraborty  ABVIMS and Dr RML hospital   Baba Kharak Singh Marg
New Delhi
DELHI 		 7666192795

anubhavchakraborty1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC ,ABVIMS and DR RML hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hemodialysis  Hemodialysis using high flux dialyser 
Comparator Agent  Hemodialysis   Hemodialysis using low flux dialyser 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients giving informed written consent
2.Patients requiring hemodialysis with serum sodium levels between 115-135 mEq/l
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of correction of Serum sodium per hour per session of hemodialysis  1 hourly 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
Mortality , MMSE Change   1 month 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

 
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