An interventional study of Sodium Bicarbonate and Placebo in Kidney Transplant; Complications and Metabolic Acidosis, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
During the treatment period, participants will receive 0.5 mEq/kg-lean body weight (LBW)/day of oral sodium bicarbonate for 8 weeks.
Drug: Sodium Bicarbonate
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.
Other: Placebo
Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening.
Also known as: Baking soda
Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.
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.
Time frame: Baseline, 8, 10, and 18 weeks
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.
Time frame: Baseline, 8, 10, and 18 weeks
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.
Time frame: Baseline, 8, 10, and 18 weeks
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver