Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

NCT ID: NCT02031770

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Metabolic Acidosis; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Treatment/Control

Patients will start with sodium bicarbonate treatment then switch to control (no treatment)

Group Type: OTHER

Sodium bicarbonate

Intervention Type: DRUG

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

Control

Intervention Type: OTHER

subjects will receive no treatment

B: Control/Treatment

Patients will start with control (no treatment) then switch to sodium bicarbonate treatment

Group Type: OTHER

Sodium bicarbonate

Intervention Type: DRUG

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

Control

Intervention Type: OTHER

subjects will receive no treatment

Interventions

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.

Intervention Type: DRUG

Control

subjects will receive no treatment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Kendrick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

13-2017

Identifier Type: -

Identifier Source: org_study_id