Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD

20-1672

This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.

2021-02-01

2023-08-30

2023-08-30

Completed

Early phase I

34

Inclusion Criteria: * Age 50-75 years old * Serum bicarbonate 16-22 mEq/L on 2 separate measurements (at least 1 day apart) * CKD stage 3b or 4 at time of screening (eGFR 15-44 ml/min/1.73m2) * Blood pressure \<130/80 mm Hg prior to randomization * Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker * Stable anti-hypertensive regimen for at least one month prior to randomization * Montreal Cognitive Assessment Score \> 24 * No history of stroke * No history of dementia * No history of neurologic disease * Able to provide consent Exclusion Criteria:• Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * Uncontrolled hypertension * Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening * New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months * Factors judged to limit adherence to interventions * Anticipated initiation of dialysis or kidney transplantation within 12 months * Current participation in another research study * Pregnancy or planning to become pregnant or currently breastfeeding * Chronic use of supplemental oxygen

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2024-05-08