Clinical Trial: Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Treatment of Metabolic Acidosis on Vascular Function in Patients With Chronic Kidney Disease: A Pilot Study

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 Summary:
Sponsor: University of Colorado, Denver

Current Primary Outcome: Change in Brachial artery flow mediated dilation (FMD) [ Time Frame: 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.


Original Primary Outcome: Brachial artery flow mediated dilation (FMD) [ Time Frame: 14 weeks ]

The primary endpoint is change in brachial artery FMD between treatment and control conditions.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Colorado, Denver

Dates:
Date Received: January 7, 2014
Date Started: January 2014
Date Completion:
Last Updated: April 29, 2016
Last Verified: April 2016