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NCT03810417 · ClinicalTrials.gov registry record · Phase 4
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 267
- Enrollment target
NCT03810417: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT03810417 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 267 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03810417, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 267 participants
- Enrollment target
Study Summary
Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called ouabain have an increased risk of developing kidney damage. This study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain levels will reduce the risk of developing kidney damage after heart surgery.
Primary Outcome
Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours
Interventions
- OTHER Placebo
- DRUG Digoxin Antibodies Fab Fragments
- DIAGNOSTIC_TEST Baseline EO > 360 pM
- DIAGNOSTIC_TEST EO < 360 pM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 4 |
What the finished NCT03810417 record still lists
NCT03810417 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03810417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03810417 about?
NCT03810417 is a clinical study titled "Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI". Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage ...
What is the current status of trial NCT03810417?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 267 participants. The study started on 2019-07-22. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT03810417?
The interventions under investigation include: Placebo (OTHER), Digoxin Antibodies Fab Fragments (DRUG), Baseline EO > 360 pM (DIAGNOSTIC_TEST), EO < 360 pM (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03810417?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03810417's enrollment target sits among peer trials
267 320th of 2000 higher than 1,681 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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