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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.

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/079956
Enrollment
398
Registered
2025-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Oral Bicarbonate Tablet: Oral Bicarbonate Tablet 500 mg twice daily on Non Dialysis days along with Bicarbonate correction during dialysis for 3 months Control Intervention1: No Oral Bi

Sponsors

INDIAN COUNCIL OF MEDICAL RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Comparing change in serum Bicarbonate level immediately before dialysis (IPD) and one day prior to dialysis (DPD) in the study groups.Timepoint: 0 and 3 months—

Secondary

MeasureTime frame
Comparing change in nutritional status (serum albumin level, pre albumin, cholesterol, bioimpedance and Subjective Global Assessment (SGA)) in study groups. Timepoint: 0 and 3 months;Change in bone turnover bio markers b-ALP, s-PINP and TRAP-5B in two study groupsTimepoint: 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 groupsTimepoint: 0 and 3 months—

Countries

India

Contacts

Public ContactSmita Divyaveer

Post Graduate Institute of Medical Education and Research, Chandigarh, India

divyaveer.ss@gmail.com8017062986

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026