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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600323
• Other study ID #: 20-1672
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Chronic Kidney Disease
• Cognitive Dysfunction
• Kidney Diseases
• Metabolic Acidosis
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium Bicarbonate Tablets
Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
• Placebo
Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Function at 12 months	Cognitive function will be determined using the NIH Toolbox-Cognition Battery computerized tests. Five major cognitive subdomains will be assessed including: 1)attention, 2)episodic memory, 3) working memory, 4) language, 5) executive function and 6)processing speed. The following summary scores will be recorded: Cognitive function composite score, Fluid cognition composite score and crystallized cognition composite score.	Baseline and 12 months
Primary	Change in Cognitive Function composite score at 12 months	NIH Toolbox will be used to assess cognitive function composite score	baseline and 12 months
Primary	Change in Fluid Cognition Composite Score at 12 months	NIH Toolbox will be used to assess fluid cognition composite score	baseline and 12 months
Primary	Change in Crystallized cognition composite score at 12 months	NIH Toolbox will be used to assess crystallized cognition score	baseline and 12 months
Secondary	Change in Cerebrovascular hemodynamics at 12 months	Cerebrovascular reactivity will be measured using Transcranial Doppler US by assessing the change in mean blood flow velocity of the middle cerebral artery in response to a vasodilatory hypercapnia challenge. Cerebrovascular pulstatility index and resistance will be determined using the Gosling Pulsatility index.	Baseline and 12 months