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

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 Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Placebo; Drug: Digoxin Antibodies Fab Fragments; Diagnostic test: Baseline EO > 360 pM; Diagnostic test: EO < 360 pM

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.

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21204
      • St Josephs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing coronary artery bypass surgery
• glomerular filtration rate > 15 History of Diabetes Mellitus or GFR < 60

Exclusion Criteria:

• Allergy to Digifab Contrast dye within 3 days Creatinine > 25% above baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digifab, EO > 360; Digifab intravenous in subject with baseline ouabain concentration > 360 pm	Drug: Digoxin Antibodies Fab Fragments; Digoxin antibodies; Diagnostic test: Baseline EO > 360 pM; Baseline ouabain concentration > 360 pM
Placebo Comparator: Placebo, EO > 360; saline intravenous n subject with baseline ouabain concentration > 360 pm	Other: Placebo; Saline; Diagnostic test: Baseline EO > 360 pM; Baseline ouabain concentration > 360 pM
Active Comparator: Digifab, EO < 360; Digifab in subject with baseline ouabain concentration < 360 pm	Drug: Digoxin Antibodies Fab Fragments; Digoxin antibodies; Diagnostic test: EO < 360 pM; Baseline ouabain concentration < 360 pM
Placebo Comparator: Placebo, EO < 360; Subjects who received Placebo in n subject with baseline ouabain concentration < 360 pm	Other: Placebo; Saline; Diagnostic test: EO < 360 pM; Baseline ouabain concentration < 360 pM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal Function	Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI	Development of AKI at 72 hours	3 days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Stephen S Gottlieb, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: acute kidney injury; coronary artery bypass surgery; ouabain
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Arrhythmia Agents; Protective Agents; Cardiotonic Agents; Digoxin; Antibodies; Immunoglobulin Fab Fragments
• Other Study ID Numbers: HP-00083553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No