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Completed

NCT Number: NCT04600323

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.

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Chronic Disease Chronic Kidney Disease Cognition Disorders Cognitive Dysfunction Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Bicarbonate Tablets

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change in Cognitive Function Composite Score at 12 Months

    Time frame: Baseline and 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.

  2. Change in Fluid Cognition Composite Score at 12 Months

    Time frame: baseline and 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

  3. Change in Crystallized Cognition Composite Score at 12 Months

    Time frame: baseline and 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.

Secondary outcomes

  1. Change in Cerebrovascular Reactivity at 12 Months

    Time frame: Baseline and 12 months

    Relative cerebrovascular reactivity was calculated as % change in mean blood flow velocity of the middle cerebral artery/(hypercapnia breath-by-breath end-tidal partial pressure of CO2 (ETCO2) minus resting ETCO2).

  2. Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months

    Time frame: Baseline and 12 months

    Measured using Transcranial Doppler Ultrasonography in response to a vasodilatory hypercapnic challenge.The change in mean blood flow velocity of the middle cerebral artery (MVMCA) was computed as the difference between hypercapnic MVMCA and normocapnic MVMCA

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2020
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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