NCT03810417

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Digoxin Antibodies Fab Fragments	Digoxin antibodies
OTHER	Placebo	Saline
DIAGNOSTIC_TEST	Baseline EO > 360 pM	Baseline ouabain concentration \> 360 pM
DIAGNOSTIC_TEST	EO < 360 pM	Baseline ouabain concentration \< 360 pM

Timeline

• Start date: 2019-07-22
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2019-01-18
• Last updated: 2025-07-02
• Results posted: 2025-07-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study