drugset / Trial / NCT03810417

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

NCT03810417 ↗

Phase 4 Completed 267 enrolled University of Maryland, Baltimore
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2019-07-22
Primary completion
2024-04-30
Completion
2024-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Digoxin Antibodies Fab Fragments Protein / enzyme biologic — Intravenous

Indications