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Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

NCT03810417 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2025-07-02

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Stephen S Gottlieb · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03810417 on ClinicalTrials.gov