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Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
Sponsor: University of Maryland, Baltimore
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.
Official title: Single System Double Blinded Trial to Evaluate the Effect of Pre-operative Treatment With DigiFab to Prevent Post-operative Acute Kidney Injury (AKI) in Patients at High Risk for AKI Undergoing Cardiac Bypass Graft Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
267
Start Date
2019-07-22
Completion Date
2024-04-30
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Digoxin Antibodies Fab Fragments
Digoxin antibodies
Placebo
Saline
Baseline EO > 360 pM
Baseline ouabain concentration \> 360 pM
EO < 360 pM
Baseline ouabain concentration \< 360 pM
Locations (2)
University of Maryland
Baltimore, Maryland, United States
St Josephs Medical Center
Baltimore, Maryland, United States