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CTRI Number  CTRI/2025/02/079956 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of oral bicarbonate therapy along with bicarbonate correction during dialysis versus bicarbonate correction in dialysis alone in patients of end stage renal disease in improving metabolic acidosis, bone heath and functional capacity. 
Scientific Title of Study   Efficacy of standard care Vs non-dialysis day bicarbonate supplementation on steady correction of metabolic acidosis in Indian CKD patients and clinical outcomes: a multicentric study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smita Divyaveer 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh, India 
Address  Department of nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12. India

Chandigarh
CHANDIGARH
160012
India 
Phone  8017062986  
Fax    
Email  divyaveer.ss@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Smita Divyaveer 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh, India 
Address  Department of nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12. India.


CHANDIGARH
160012
India 
Phone  8017062986  
Fax    
Email  divyaveer.ss@gmail.com  
 
Details of Contact Person
Public Query  
Name  Smita Divyaveer 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh, India 
Address  Department of nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector 12. India.


CHANDIGARH
160012
India 
Phone  8017062986  
Fax    
Email  divyaveer.ss@gmail.com  
 
Source of Monetary or Material Support  
INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  INDIAN COUNCIL OF MEDICAL RESEARCH 
Address  INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Koushik Bhattacharjee  Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital  Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Bhowanipore, Kolkata
Kolkata
WEST BENGAL 		 9831123712

doc.koushikbhattacharjee@gmail.com 
Dr Malagouda R Patil  Karnataka Medical College and Research Institute Hubballi  Karnataka Medical College and Research Institute Hubballi.pin 580022
Dharwad
KARNATAKA 		 9741376267

mallunsp67@gmail.com 
Dr Smita Divyaveer  Post Graduate Institute of Medical Education and Research, Chandigarh. India  Post Graduate Institute of Medical Education and Research, Chandigarh. India.
Chandigarh
CHANDIGARH 		 8017062986

divyaveer.ss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute of Post-Graduate Medical Education and Research Research oversight committee  Approved 
Institutional Ethics Committee For Biomedical and Health Research Post Graduate Institute of Medical Education and Research, Chandigarh, India.  Approved 
Karnataka Medical college and research institute, Hubballi 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 
Comparator Agent  No Oral Bicarbonate Tablet  Bicarbonate correction during dialysis alone with no oral bicarbonate for 3 months 
Intervention  Oral Bicarbonate Tablet  Oral Bicarbonate Tablet 500 mg twice daily on Non Dialysis days along with Bicarbonate correction during dialysis for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All CKD adult patients on hemodialysis aged 18 to 65 years
2. Stable on hemodialysis more than 12 weeks
3. Immediately pre-dialysis serum bicarb concentration 22 mEq per L
 
 
ExclusionCriteria 
Details  1. Moribund patient : Patients with any condition at the time of randomization who likely to within 3 months as deemed by treating physician.
2. Mentally ill :Any patient with diagnosed psychiatric condition or receiving psychiatric treatment of any kind will be excluded from the study.
3. No acute illnesses, any respiratory and cardiovascular disease and sever liver disease. .
5. Patients with history of stroke
6. bed ridden patients
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparing change in serum Bicarbonate level immediately before dialysis (IPD) and one day prior to dialysis (DPD) in the study groups.  0 and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing change in nutritional status (serum albumin level, pre albumin, cholesterol, bioimpedance and Subjective Global Assessment (SGA)) in study groups.
 		 0 and 3 months 
Change in bone turnover bio markers b-ALP, s-PINP and TRAP-5B in two study groups  0 and 3 months 
To assess change in muscle strength and function (Handgrip strength and short physical performance battery: Gait speed, sit to stand test and static balance test) among two study groups  0 and 3 months 
 
Target Sample Size   Total Sample Size="398"
Sample Size from India="398" 
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   N/A 
Date of First Enrollment (India)   17/02/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  INDIAN COUNCIL OF MEDICLA RESEARCH DATA REPOSITORY

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  INDIAN COUNCIL OF MEDICLA RESEARCH DATA REPOSITORY

  6. For how long will this data be available start date provided 17-02-2025 and end date provided 31-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Summary: Rationale: Hemodialysis corrects metabolic acidosis in saw tooth manner with risk of alkalosis and over correction on dialysis days and acidosis on non-dialysis days. In resource limited settings, bicarbonate levels are rarely tested due to poor follow-up, unavailability of nephrologists, geographic and cost constraints.
Chronic metabolic acidosis with intermittent correction leads to hyperkalemia and worse outcomes of bone health, catabolic state and cardiovascular events.
Western data on bicarbonate supplementation and dialysis cannot be applied due to different dietary patterns, affordability and availability of dialysis.
Novelty: We propose a pragmatic, real world study in Indian dialysis patients to assess efficacy of steady correction of metabolic acidosis without altering dialysis regime, using a relatively inexpensive medication i.e. oral Bicarbonate on non dialysis days versus routine care consisting of acidosis correction only during dialysis. Objectives: Comparing change in serum Bicarbonate level immediately prior to dialysis (IPD) and one day prior to dialysis (DPD), bone turnover bio markers (b-ALP, s-PINP and TRAP-5B), nutritional status, muscle strength and function in study groups.
Methods: Intervention arm patients will be given Oral bicarbonate as per protocol. Bicarbonate levels will be measured per 2 weeks. Clinical investigations will be recorded and blood samples will be collected at baseline and follow-up at all study sites. Nutritional status will be monitored using bioimpedence and ‘SGA format for CKD’. Bone turnover will be analyzed using ELISA. Muscle strength and functionality will be tested using various exercises and dynamometry.
Expected Outcomes: will be applicable to all Indian patients on dialysis.If found effective, this will establish the usefulness of a relatively inexpensive measure to improve outcomes in CKD. 
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