Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

  • End date
    Dec 26, 2021
  • participants needed
  • sponsor
    University of Maryland, Baltimore
Updated on 26 January 2021
Stephen Gottlieb, MD
Primary Contact
St Josephs Medical Center (9.3 mi away) Contact
+1 other location
glomerular filtration rate
renal injury
heart surgery
coronary artery bypass graft


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.


This is a randomized double-blinded study investigating the role of DigiFab in patients with elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a follow up period of 72 hours post CABG surgery.

Condition Renal Failure, Acute renal failure, Kidney Failure (Pediatric), Kidney Failure, acute kidney injury, acute kidney injuries
Treatment Placebo, Digoxin Antibodies Fab Fragments
Clinical Study IdentifierNCT03810417
SponsorUniversity of Maryland, Baltimore
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Undergoing coronary artery bypass surgery
glomerular filtration rate > 15 History of Diabetes Mellitus or GFR < 60

Exclusion Criteria

Allergy to Digifab Contrast dye within 3 days Creatinine > 25% above baseline
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