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High versus standard alkali supplementation in kidney disease

Comparison of the effect of metabolic acidosis correction of Venous bicarbonate level of 26-28 meq/L with standard correction of 22-24 meq/L to preserve kidney function in patients with non protienuric Chronic Kidney Disease- A Randomised clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027100
Enrollment
134
Registered
2020-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Sodium bicarbonate tablets: Sodium bicarbonate wil be given to keep taget venous bicarbonate at 26-28 meq/L Control Intervention1: Sodium bicarbonate tablets: Sodium bicarbonate wil be

Sponsors

Jawaharlal Institute of postgraduate Medical Education Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All prevalent adult CKD stages 3b, 4 and 5D patients with a minimum follow-up duration of 6 months in Nephrology OPD. 2. Serum bicarbonate (venous) levels below 22meq/L without bicarbonate supplementation. 3. Stable kidney function (defined as eGFR fluctuation of less than 2ml/min/1.73m2 in the preceding 3 months) 4. 24-hour urine protein excretion less than 1g.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of congestive heart failure with New York heart association (NYHA) class 3 or 4 symptoms 2. History of diabetes or fasting plasma glucose >=126mg/dL and/or post prandial plasma glucose >= 200mg/dL and/or glycosylated hemoglobin (HbA1c) >= 6.5 3. Use of four or more antihypertensives for blood pressure control 4. Clinical evidence of volume overload/hypocalcemia/hypercapnea 5. Serum potassium =5.5meq/L 6. Serum creatinine 7. Decompensated chronic liver disease 8. Kidney transplant recipient 9. Receiving Immunosuppressive drug therapy 10. Active pregnancy 11. Expected to be initiated on dialysis in the next 6 months as assessed by the treating physician. 12. Those who had acute kidney injury (according to KDIGO criteria) in the preceding 3 months. 13. Cystic Kidney disease 14. Obstructive uropathy

Design outcomes

Primary

MeasureTime frame
To assess the effect of metabolic acidosis correction with Venous bicarbonate level of 26-28 meq/L when compared to standard correction of 22-24 meq/L on Kidney function among the patients with non protienuric Chronic Kidney Disease (stages 3 b, 4 and 5 ND)Timepoint: 0 and 3 months—

Secondary

MeasureTime frame
To compare the effect of metabolic acidosis correction with Venous bicarbonate level of 26-28 meq/L when compared to standard correction of 22-24 meq/L on , TGF beta , oxidative stress, urine ammonia , peripheral vascular resistance and insulin resistance among the patients with non protienuric Chronic Kidney DiseaseTimepoint: 0 and 3 months;To compare the tolerability,adherance and safety of metabolic acidosis correction with Venous bicarbonate level of 26-28 meq/L when compared to standard correction of 22-24 meq/L among the patients with non protienuric Chronic Kidney DiseaseTimepoint: 0 and 3 months—

Countries

India

Contacts

Public ContactDr Swathy Raju

JIPMER

swathiraju7777@gmail.com9447753585

Outcome results

None listed

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