Kidney Transplant; Complications Clinical Trial
Official title:
Bicarbonate Administration in Kidney Transplant Recipients
NCT number | NCT03428464 |
Other study ID # | 17-2317 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 5, 2018 |
Est. completion date | March 25, 2020 |
Verified date | October 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 25, 2020 |
Est. primary completion date | March 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Kidney transplant received at least 1 year ago - Serum bicarbonate 20-26 mEq/L on 2 separate measurements (at least 1 day apart) - eGFR >45 ml/min/1.73m2 - Blood pressure <140/90 mm Hg prior to randomization - BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients). - Able to provide consent - Stable kidney transplant medication regimen for at least 1 month prior to randomization - Stable anti-hypertensive regimen for at least one month prior to randomization - Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin). 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 ยท Factors judged to limit adherence to interventions - Current participation in another research study - Pregnancy or planning to become pregnant or currently breastfeeding - Chronic use of supplemental oxygen |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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