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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Early Phase 1

Conditions: Chronic Kidney Disease; Cognitive Dysfunction; Metabolic Acidosis

Treatments: Drug: Placebo; Drug: Sodium Bicarbonate Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04600323

20-1672

R21AG068657 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day

Treatment:

Drug: Placebo

Sodium bicarbonate

Experimental group

Description:

Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day.

Treatment:

Drug: Sodium Bicarbonate Tablets