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Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02031770
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Denver Health and Hospital Authority
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Metabolic Acidosis Chronic Kidney Disease Drug: Sodium bicarbonate Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Treatment of Metabolic Acidosis on Vascular Function in Patients With Chronic Kidney Disease: A Pilot Study
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
A: Treatment/Control
Patients will start with sodium bicarbonate treatment then switch to control (no treatment)
Drug: Sodium bicarbonate
Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.

Other: Control
subjects will receive no treatment

B: Control/Treatment
Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
Drug: Sodium bicarbonate
Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.

Other: Control
subjects will receive no treatment




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031770


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02031770    
Other Study ID Numbers: 13-2017
First Posted: January 9, 2014    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
vascular endothelial cells
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases