Bicarbonate Administration in Kidney Transplant Recipients
Completed · Not applicable · Has a placebo group
Conditions studied: Kidney Transplant; Complications, Metabolic Acidosis
In brief
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.
Key facts
- Study ID
- NCT03428464
- Run by
- University of Colorado, Denver
- People needed
- 20
- Starts
- 2018-12-05
- Expected to finish
- 2020-03-25
- Last updated by the study team
- 2020-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- Current participation in another research study
- Pregnancy or planning to become pregnant or currently breastfeeding
- Chronic use of supplemental oxygen
Where it is running
- University of Colorado Hospital — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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