Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Digoxin Antibodies Fab Fragments; Other: Placebo; Diagnostic Test: Baseline EO > 360 pM; Diagnostic Test: EO < 360 pM

• Registration Number: NCT03810417
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-07-22
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Results First Submitted: 2025-05-07
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Results First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digifab, EO > 360	Digoxin Antibodies Fab Fragments	Digifab intravenous in subject with baseline ouabain concentration \> 360 pm
Digifab, EO > 360	Baseline EO > 360 pM	Digifab intravenous in subject with baseline ouabain concentration \> 360 pm
Placebo, EO > 360	Placebo	saline intravenous n subject with baseline ouabain concentration \> 360 pm
Placebo, EO > 360	Baseline EO > 360 pM	saline intravenous n subject with baseline ouabain concentration \> 360 pm
Digifab, EO < 360	Digoxin Antibodies Fab Fragments	Digifab in subject with baseline ouabain concentration \< 360 pm
Digifab, EO < 360	EO < 360 pM	Digifab in subject with baseline ouabain concentration \< 360 pm
Placebo, EO < 360	Placebo	Subjects who received Placebo in n subject with baseline ouabain concentration \< 360 pm
Placebo, EO < 360	EO < 360 pM	Subjects who received Placebo in n subject with baseline ouabain concentration \< 360 pm
Digifab	Digoxin Antibodies Fab Fragments	Digifab intravenous
Placebo	Placebo	saline intravenous

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
AKI	3 days	Development of AKI at 72 hours

Trial Locations

Locations (2)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

St Josephs Medical Center; 🇺🇸 Baltimore, Maryland, United States