Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:40 - 70
Updated:4/21/2016
Start Date:January 2014
End Date:June 2016
Contact:Jessica B Kendrick, MD
Email:Jessica.Kendrick@ucdenver.edu
Phone:3036025012

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

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.


Inclusion Criteria

:• Age 40-70 years

- CKD stage IV (eGFR 15-29 ml/min/1.73m2; stable renal function in the past 3 months)

- Serum bicarbonate level of < 20 and ≥ 16 meq/L (at least 2 consecutive weekly
measurements)

- Body mass index < 40 kg/m2 (FMD measurements can be inaccurate in severely obese
patients)

- Ability to give informed consent

- Stable anti-hypertensive, diabetic and lipid lowering regimen for at least one month
prior to randomization

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
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Jessica Kendrick, MD
Phone: 303-602-5012
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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