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Metabolic acidosis is associated with vascular endothelial dysfunction and is a common complication in patients who have received a kidney transplant. Kidney transplant recipients (KTR) with lower serum bicarbonate levels, even within the normal range, have an increased risk of graft loss and mortality. The investigators propose a prospective, double-blind, randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of sodium bicarbonate on vascular endothelial function, graft function, and cognitive function in 20 KTR patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate | Experimental | During the treatment period, participants will receive 0.5 mEq/kg-lean body weight (LBW)/day of oral sodium bicarbonate for 8 weeks. |
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| Placebo | Placebo Comparator | During the control period, participants will take the same number of placebo capsules as if they were assigned 0.5 mEq/kg-LBW/day of sodium bicarbonate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate | Drug | Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Brachial Artery Flow-Mediated Dilation | Brachial artery Flow-Mediated Dilation (FMD) will be determined using high-resolution ultrasonography (Toshiba Xario 200) as described originally by Celermajer et al., and more recently by our group. FMD will be measured at the beginning and end of each study period for a total of 4 measurements. ECG-gated end-diastolic ultrasound images and Doppler flow of the brachial artery will be acquired during baseline and FMD conditions. | Baseline, 8, 10, and 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Transforming Growth Factor Beta 1 (TGF-B1) | Urinary TGF-B1 will be measured from 24-hour urine collections. It will be measured by a commercially available ELISA (R&D Systems). The within day precision for this assay is 6.7% at 257 pg/ml. All measurements will be performed at the Children's Pediatric CTRC at Children's Hospital Colorado. | Baseline, 8, 10, and 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Kendrick, MD MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 | Other | Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening. |
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| Change in Cognitive Function | Cognitive function will be assessed using the National Institutes of Health (NIH) Toolbox computerized tests to evaluate 1) attention, 2) episodic memory, 3) working memory, 4) language, 5) executive function, and 6) processing speed. | Baseline, 8, 10, and 18 weeks |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |