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Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

Primary Purpose

Metabolic Acidosis, Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium bicarbonate
Control
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis focused on measuring vascular endothelial cells

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A: Treatment/Control

B: Control/Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2014
Last Updated
September 3, 2020
Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02031770
Brief Title
Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease
Official Title
Effect of Treatment of Metabolic Acidosis on Vascular Function in Patients With Chronic Kidney Disease: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis, Chronic Kidney Disease
Keywords
vascular endothelial cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Treatment/Control
Arm Type
Other
Arm Description
Patients will start with sodium bicarbonate treatment then switch to control (no treatment)
Arm Title
B: Control/Treatment
Arm Type
Other
Arm Description
Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
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
Other
Intervention Name(s)
Control
Intervention Description
subjects will receive no treatment
Primary Outcome Measure Information:
Title
Change in Brachial Artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
6 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Kendrick, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

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