Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

NCT02031770 | Completed Results

• 1 other identifier: 13-2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

vascular endothelial cells

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A: Treatment/Control

OTHER

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

Drug: Sodium bicarbonate; Other: Control

B: Control/Treatment

OTHER

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

Drug: Sodium bicarbonate; Other: Control

Interventions

Sodium bicarbonate 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.

A: Treatment/Control; B: Control/Treatment

Control OTHER

subjects will receive no treatment

A: Treatment/Control; B: Control/Treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Denver Health and Hospital Authority: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Acidosis; Renal Insufficiency, Chronic

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jessica Kendrick
• Organization: University of Colorado Denver

Jessica.Kendrick@ucdenver.edu

3037244837

Study Officials

• Jessica Kendrick, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)