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NCT03428464 · ClinicalTrials.gov registry record · NA
Bicarbonate Administration in Kidney Transplant Recipients
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03428464: Completed NA study, sponsored by University of Colorado, Denver.
NCT03428464 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03428464, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
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.
Primary Outcome
Brachial artery Flow-Mediated Dilation (FMD) will be determined using high-resolution ultrasonography (Toshiba Xario 200) as described originally by Celermajer et al., and more recently by our group. FMD will be measured at the beginning and end of each study period for a total of 4 measurements. ECG-gated end-diastolic ultrasound images and Doppler flow of the brachial artery will be acquired during baseline and FMD conditions.
Interventions
- OTHER Placebo
- DRUG Sodium Bicarbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2020-03-25 |
| Phase | NA |
What the finished NCT03428464 record still lists
NCT03428464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03428464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03428464 about?
NCT03428464 is a clinical study titled "Bicarbonate Administration in Kidney Transplant Recipients". 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 mortal...
What is the current status of trial NCT03428464?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-12-05. Estimated completion is 2020-03-25.
What interventions are being tested in trial NCT03428464?
The interventions under investigation include: Placebo (OTHER), Sodium Bicarbonate (DRUG).
Who is sponsoring clinical trial NCT03428464?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03428464's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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