N/A
Completed N=109
Bicarbonate Administration in CKD
Chronic Kidney Disease · Metabolic Acidosis
Source: ClinicalTrials.gov NCT02915601 ↗
Enrolled (actual)
109
Serious AEs
12.8%
Results posted
Jul 2023
Primary outcomePrimary: Change in Brachial Artery Flow Mediated Dilation — 3.99; 3.78; 4.25; 4.43 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brachial Artery Flow Mediated Dilation |
3.99; 3.78; 4.25; 4.43 | — |
| PRIMARY Change in Aortic Pulse Wave Velocity |
998.3; 994.8; 1067.2; 983.4 | — |
| SECONDARY Change in Left Ventricular Mass Index |
57.4; 59.4; 57.2; 67.6 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02915601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.