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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 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 267 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03810417
The ClinicalTrials.gov registry entry for NCT03810417 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03810417 reports 0 study locations.
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.
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