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Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

Not Applicable
Completed
Conditions
Metabolic Acidosis
Chronic Kidney Disease
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria
  • 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
GroupInterventionDescription
A: Treatment/ControlControlPatients will start with sodium bicarbonate treatment then switch to control (no treatment)
B: Control/TreatmentControlPatients will start with control (no treatment) then switch to sodium bicarbonate treatment
A: Treatment/ControlSodium bicarbonatePatients will start with sodium bicarbonate treatment then switch to control (no treatment)
B: Control/TreatmentSodium bicarbonatePatients will start with control (no treatment) then switch to sodium bicarbonate treatment
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

University of Colorado Denver

🇺🇸

Aurora, Colorado, United States

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