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COMPLETED
NCT03810417
PHASE4

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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

Interventions

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

Locations (2)

University of Maryland

Baltimore, Maryland, United States

St Josephs Medical Center

Baltimore, Maryland, United States