Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease
- Conditions
- Metabolic AcidosisChronic Kidney Disease
- Interventions
- Other: Control
- Registration Number
- NCT02031770
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic acidosis is a common complication of CKD resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not been evaluated. The investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV with metabolic acidosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
- Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- Uncontrolled hypertension
- Expected to undergo living related kidney transplant in next 6 months
- Expected to start dialysis in next 3 months
- Overt congestive heart failure
- Use of sevelamer
- Use of calcium carbonate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A: Treatment/Control Control Patients will start with sodium bicarbonate treatment then switch to control (no treatment) B: Control/Treatment Control Patients will start with control (no treatment) then switch to sodium bicarbonate treatment A: Treatment/Control Sodium bicarbonate Patients will start with sodium bicarbonate treatment then switch to control (no treatment) B: Control/Treatment Sodium bicarbonate Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
- Primary Outcome Measures
Name Time Method Change in Brachial Artery Flow Mediated Dilation (FMD) 6 weeks and 12 weeks The primary endpoint is change in brachial artery FMD between treatment and control conditions. Each treatment period is 6 weeks in duration with a 2 week washout period in between. Outcome measures will be repeated at the beginning and end of each period.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado Denver
🇺🇸Aurora, Colorado, United States