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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver

Criteria

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