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CTRI Number  CTRI/2021/12/039048 [Registered on: 30/12/2021] Trial Registered Prospectively
Last Modified On: 18/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of individualized sodium levels in dialysis fluid on weight gains 
Scientific Title of Study   Effect of Individualized Dialysate Sodium for maintenance hemodialysis patients in tertiary hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vipul Sanghavi 
Designation  Resident nephrology 
Affiliation  KEM Hospital, Pune 
Address  Renal Unit, 2nd floor, Diamond Jubilee Building, KEM Hospital, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9860495806  
Fax    
Email  vipulsanghavi89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipul Sanghavi 
Designation  Resident nephrology 
Affiliation  KEM Hospital, Pune 
Address  Renal Unit, 2nd floor, Diamond Jubilee Building, KEM Hospital, Rasta Peth, Pune


MAHARASHTRA
411011
India 
Phone  9860495806  
Fax    
Email  vipulsanghavi89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Valentine Lobo 
Designation  Consultant Nephrologist 
Affiliation  KEM Hospital, Pune 
Address  Renal Unit, 2nd floor, Diamond Jubilee Building, KEM Hospital, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone    
Fax    
Email  valentinelobo702@gmail.com  
 
Source of Monetary or Material Support  
KEM Hospital, Pune 
 
Primary Sponsor  
Name  KEM Hospital 
Address  Sardar Moodliar Road, Rasta Peth 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vipul Sanghavi  KEM Hospital  Renal Unit, 2nd floor Diamond Jubilee Building, Department of medicine Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA 		 02066037363

vipulsanghavi89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Center Ethics Committee  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  Individualized dialysate sodium  Dialysis fluids sodium level will be set with the help of the dialysis machine to be around 2 mEq/L higher than the patients blood sodium levels.  
Comparator Agent  Standard Dialysate Sodium  Currently, all over the world an arbitrarily set level fo dialysate sodium is used. This differs from the unit to unit. We use 136mEq/L value as standard 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Chronic kidney disease stage 5D patients on maintenance hemodialysis
2. Achieved dry weight as per clinical or bio-impedence estimation, with minimal manipulation 
 
ExclusionCriteria 
Details  1) Patients dialyzing less than 3/week
2) Life expectancy < 6 months
3) Failure to consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Weight gain between two dialysis sessions  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in systolic blood pressure before the hemodialysis session   2 months 
Episodes of hypotension or hypertension during dialysis  2 months 
Change in the requirement of BP medicines  2 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/01/2022 
Date of Study Completion (India) 27/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The results will be published in a scientific journal without revealing the identity of the participants 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dialysate, i.e. fluid which is used for dialysis has sodium as an important constituent. The level of dialysate sodium determines various aspects of the dialysis session such as blood pressure, thirst after dialysis and the weight gain between two dialysis sessions. Currently, all patients undergoing dialysis worldwide are dialyzed with dialysate sodium which is arbitrarily set, irrespective of their blood sodium levels. A dialysate sodium concentration higher than the patient’s own blood sodium level can contribute to increased thirst, weight gain in between the dialysis and increase in blood pressure. Using individualized dialysate sodium is thought to avoid addition of excess sodium and water to the patient’s body.

In this study we aim to study the effect of individualizing the dialysate sodium (near to the patient’s blood sodium levels) on weight gain between two dialysis sessions, blood pressure before dialysis, requirement of blood-pressure-lowering medications and also on the blood pressure during dialysis. 
We are randomizing the participants based on a fixed protocol to either receive individialized dialysate sodium (2 mEq above patient’s own blood sodium levels) or to receive standard dialysate sodium of 136 mEq/L- which is current standard of care. After 1 month, the patient will switch the groups and will receive the other group’s sodium level in the dialysis fluid. The monitoring will be done to see weight gains between two dialysis sessions in both groups.
As a close monitoring is always done during the hemodialysis session, risk to the participants is less. All fluctuations in blood pressure in both arms of the study will be dealt with using standard protocols. 


 
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