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: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Placebo; Drug: Digoxin Antibodies Fab Fragments

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 (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stephen Gottlieb, MD; Phone Number: 4103288788; Email: sgottlie@medicine.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Stephen Gottlieb, MD; Phone Number: 410-328-8788; Email: sgottlie@medicine.umaryland.edu
    • Baltimore, Maryland, United States, 21204
      • Not yet recruiting
      • St Josephs Medical Center
      • Contact: Stephen Gottlieb; Phone Number: 410-328-8788; Email: sgottlie@medicine.umaryland.edu

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digifab; Digifab intravenous	Drug: Digoxin Antibodies Fab Fragments; Digoxin antibodies
Placebo Comparator: Placebo; saline intravenous	Other: Placebo; Saline

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	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for dialysis	Number of patients with any dialysis given within 30 days of surgery	30 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 (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 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 (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: acute kidney injury; coronary artery bypass surgery; ouabain
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Immunologic Factors; 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