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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG068657 | U.S. NIH Grant/Contract | View source |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day |
|
| Sodium bicarbonate | Experimental | Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate Tablets | Drug | Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebrovascular Reactivity at 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). | Baseline and 12 months |
| Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:• Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40797182 | Derived | Gu F, You Z, Hawkins N, Reddin R, Hamour R, Shapiro A, Coughlan C, Seals D, Furgeson S, Dixon A, Nowak KL, Kendrick J. Effects of sodium bicarbonate therapy on cognitive and cerebrovascular function in midlife and older adults with chronic kidney disease: a pilot randomized trial. BMC Nephrol. 2025 Aug 12;26(1):454. doi: 10.1186/s12882-025-04388-6. | |
| 37889573 | Derived | Perez L, You Z, Kendrick J. Association of Plant-Based Protein Intake with Cognitive Function in Adults with CKD. Kidney360. 2023 Nov 1;4(11):1554-1561. doi: 10.34067/KID.0000000000000278. Epub 2023 Oct 27. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months |
| FG001 | Sodium Bicarbonate | Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months |
| BG001 | Sodium Bicarbonate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | T-score | Baseline and 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dialysis initiation | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Kendrick | University of Colorado Denver | 3037244837 | jessica.kendrick@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2023 | Dec 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| D051436 | Renal Insufficiency, Chronic |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Placebo | Drug | Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months |
|
| 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 |
| Baseline and 12 months |
Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day.
Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Bicarbonate (mEq/L) | Mean | Standard Deviation | mEq/L |
|
| GFR (ml/min/1.73m2) | Mean | Standard Deviation | ml/min/1.73m2 |
|
| OG001 | Sodium Bicarbonate | Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | T-score | baseline and 12 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | T-score | baseline and 12 months |
|
|
|
| Secondary | Change in Cerebrovascular Reactivity at 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). | Posted | Mean | Standard Deviation | percent change/mmHg | Baseline and 12 months |
|
|
|
| Secondary | Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 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 | Posted | Mean | Standard Deviation | percent change | Baseline and 12 months |
|
|
|
| 0 |
| 16 |
| 7 |
| 16 |
| 6 |
| 16 |
| EG001 | Sodium Bicarbonate | Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months | 0 | 18 | 6 | 18 | 13 | 18 |
| Hospitalization | Infections and infestations | Systematic Assessment |
|
| New Lower Extremity Edema | Cardiac disorders | Systematic Assessment |
|
| Increase in antihypertensive therapy | Cardiac disorders | Systematic Assessment |
|
| Increase in diuretic therapy | Cardiac disorders | Systematic Assessment |
|
| High serum bicarbonate level | Renal and urinary disorders | Systematic Assessment |
|
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| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |