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Bicarbonate Administration in Kidney Transplant Recipients

NCT03428464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-10-22

No results posted yet for this study

Summary

Metabolic acidosis is associated with vascular endothelial dysfunction and is a common complication in patients who have received a kidney transplant. Kidney transplant recipients (KTR) with lower serum bicarbonate levels, even within the normal range, have an increased risk of graft loss and mortality. The investigators propose a prospective, double-blind, randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of sodium bicarbonate on vascular endothelial function, graft function, and cognitive function in 20 KTR patients.

Conditions

  • Kidney Transplant; Complications
  • Metabolic Acidosis

Interventions

DRUG

Sodium Bicarbonate

Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening.

OTHER

Placebo

Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jessica Kendrick, MD MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428464 on ClinicalTrials.gov