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

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

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.

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