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NCT Number: NCT02031770

Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

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.

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Key information

Conditions

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

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Other

subjects will receive no treatment

Primary outcomes

  1. Change in Brachial Artery Flow Mediated Dilation (FMD)

    Time frame: 6 weeks and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Denver Health and Hospital Authority

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2014
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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