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

Early Phase 1CompletedNCT04600323

University of Colorado, Denver34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Metabolic Acidosis Chronic Kidney Disease Cognitive Dysfunction

Interventions

Sodium Bicarbonate TabletsDRUG

Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months

PlaceboDRUG

Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in Cognitive Function Composite Score at 12 Months

Cognitive function will be determined using the NIH Toolbox-Cognition Battery computerized tests. The Cognitive function composite score is based on the average of the Fluid and Crystallized composites. It is derived by averaging the Fluid and Crystallized standard scores, then deriving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

Time frame: Baseline and 12 months

Change in Fluid Cognition Composite Score at 12 Months

NIH Toolbox will be used to assess fluid cognition composite score. This score includes all the tests that are measuring fluid ability: Flanker, Dimensional Change, Picture sequence memory, list sorting and pattern comparison. The composite score is derived by averaging the standard scores of each of the measures. Fully Corrected T-scores are adjusted for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. A fully corrected T-score at or near 50 (population mean with standard deviation of 10) indicates ability that is average compared with others nationally and one below 40 suggests the possibility of cognitive impairment. N

Time frame: baseline and 12 months

Change in Crystallized Cognition Composite Score at 12 Months

NIH Toolbox will be used to assess crystallized cognition composite score. This composite score includes the picture vocabulary and reading tests. The composite score is derived by averaging the standard scores of each of the measure, and then driving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. A fully corrected T-score at or near 50 (population mean with standard deviation of 10) indicates ability that is average compared with others nationally as the mean T-score is 50 nationally. A score higher than 50 indicates better crystallized cognition.

Data from ClinicalTrials.gov

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