Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031770
• Other study ID #: 13-2017
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Chronic Kidney Disease
• Kidney Diseases
• Metabolic Acidosis
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium bicarbonate
Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of = 23 meq/L.

Other:
• Control
subjects will receive no treatment

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brachial Artery Flow Mediated Dilation (FMD)	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.	6 weeks and 12 weeks