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

Primary Purpose

Metabolic Acidosis, Chronic Kidney Disease, Cognitive Dysfunction

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sodium Bicarbonate Tablets
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Sodium bicarbonate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Change in Cognitive Function composite score at 12 months
NIH Toolbox will be used to assess cognitive function composite score
Change in Fluid Cognition Composite Score at 12 months
NIH Toolbox will be used to assess fluid cognition composite score
Change in Crystallized cognition composite score at 12 months
NIH Toolbox will be used to assess crystallized cognition score

Secondary Outcome Measures

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.

Full Information

First Posted
October 19, 2020
Last Updated
April 18, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04600323
Brief Title
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
Official Title
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis, Chronic Kidney Disease, Cognitive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day
Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day.
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate Tablets
Intervention Description
Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months
Primary Outcome Measure Information:
Title
Change in Cognitive Function at 12 months
Description
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.
Time Frame
Baseline and 12 months
Title
Change in Cognitive Function composite score at 12 months
Description
NIH Toolbox will be used to assess cognitive function composite score
Time Frame
baseline and 12 months
Title
Change in Fluid Cognition Composite Score at 12 months
Description
NIH Toolbox will be used to assess fluid cognition composite score
Time Frame
baseline and 12 months
Title
Change in Crystallized cognition composite score at 12 months
Description
NIH Toolbox will be used to assess crystallized cognition score
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in Cerebrovascular hemodynamics at 12 months
Description
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.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.

Learn more about this trial

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

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