Bicarbonate Administration in CKD

Chronic Kidney Disease Clinical Trial

Official title:

Bicarbonate Administration in CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915601
• Other study ID #: 16-1572
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: May 19, 2022

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acidosis
• Chronic Kidney Disease
• Kidney Diseases
• Metabolic Acidosis
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium bicarbonate

• Placebo

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brachial Artery Flow Mediated Dilation		Measured at baseline and 12 months
Primary	Change in Aortic Pulse Wave Velocity		Measured at baseline,12 months
Secondary	Change in Left Ventricular Mass Index		Measured at baseline and 12 months