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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    50
  • sponsor
    University of Colorado, Denver
Updated on 19 December 2021

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.

Details
Condition Metabolic Acidosis, Chronic Kidney Disease, Cognitive Dysfunction
Treatment Placebo, Sodium Bicarbonate Tablets
Clinical Study IdentifierNCT04600323
SponsorUniversity of Colorado, Denver
Last Modified on19 December 2021

Eligibility

Yes No Not Sure

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
Factors judged to limit adherence to interventions
New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or
Anticipated initiation of dialysis or kidney transplantation within 12 months
hospital admission for heart failure within the past 3 months
Current participation in another research study
Pregnancy or planning to become pregnant or currently breastfeeding
Chronic use of supplemental oxygen
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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