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OpenTrials
Completed

NCT Number: NCT02915601

Bicarbonate Administration in CKD

Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. The current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (CKD) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. Overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with CKD to decrease the risk of developing cardiovascular diseases.

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Key information

Conditions

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

Age range

21 year–80 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 ≥ 21 years
  • Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart)
  • CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
  • Blood pressure <130/80 mm Hg prior to randomization
  • BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
  • Able to provide consent
  • Stable anti-hypertensive regimen for at least one month prior to randomization
  • Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion criteria

  • Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
  • Uncontrolled hypertension
  • Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening
  • New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
  • Factors judged to limit adherence to interventions
  • Anticipated initiation of dialysis or kidney transplantation within 12 months
  • Current participation in another research study
  • Pregnancy or planning to become pregnant or currently breastfeeding
  • Chronic use of supplemental oxygen
  • Use of immunosuppression in past 3 months
  • Metal implant or implanted electrical device (patient will be unable to get MRI)

Treatment and study plan

Sodium bicarbonate

Drug

Placebo

Drug

Primary outcomes

  1. Change in Brachial Artery Flow Mediated Dilation

    Time frame: Measured at baseline and 12 months

  2. Change in Aortic Pulse Wave Velocity

    Time frame: Measured at baseline,12 months

Secondary outcomes

  1. Change in Left Ventricular Mass Index

    Time frame: Measured at baseline and 12 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2016
Registry last updated
Jul 25, 2023

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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