At a glance
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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
In Brief
A Phase 4 clinical trial evaluating Digoxin Antibodies Fab Fragments, Placebo, and 2 other interventions for Acute Kidney Injury. Completed, enrolled 267 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Digoxin antibodies
Saline
Baseline ouabain concentration \> 360 pM
Baseline ouabain concentration \< 360 pM