Phase 4
N=267
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT03810417 ↗Enrolled (actual)
267
Serious AEs
26.8%
Results posted
Jul 2025
Primary outcome: Primary: Renal Function — .46; .75; 4.26; 2.80 mL/min/1.73m^2 — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Digoxin Antibodies Fab Fragments (Drug); Placebo (Other); Baseline EO > 360 pM (Diagnostic_test); EO < 360 pM (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function |
.46; .75; 4.26; 2.80 | >0.05 |
| SECONDARY AKI |
5; 12; 8; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Undergoing coronary artery bypass surgery
- glomerular filtration rate > 15 History of Diabetes Mellitus or GFR 25% above baseline
Data sourced from ClinicalTrials.gov (NCT03810417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.