Status:
COMPLETED
Bicarbonate Administration in Kidney Transplant Recipients
Lead Sponsor:
University of Colorado, Denver
Conditions:
Kidney Transplant; Complications
Metabolic Acidosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ser...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03428464
Start Date
December 5 2018
End Date
March 25 2020
Last Update
October 22 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045