Working… Menu

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03810417
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland, College Park

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Digoxin Antibodies Fab Fragments Other: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients undergoing coronary artery bypass surgery
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigational pharmacy will provide active drug or placebo
Primary Purpose: Prevention
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
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Active Comparator: Digifab
Digifab intravenous
Drug: Digoxin Antibodies Fab Fragments
Digoxin antibodies

Placebo Comparator: Placebo
saline intravenous
Other: Placebo

Primary Outcome Measures :
  1. Renal function [ Time Frame: 72 hours ]
    Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2

Secondary Outcome Measures :
  1. Need for dialysis [ Time Frame: 30 days ]
    Number of patients with any dialysis given within 30 days of surgery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03810417

Layout table for location contacts
Contact: Stephen Gottlieb, MD 4103288788

Layout table for location information
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stephen Gottlieb, MD    410-328-8788   
St Josephs Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21204
Contact: Stephen Gottlieb    410-328-8788   
Sponsors and Collaborators
University of Maryland, Baltimore
Layout table for investigator information
Principal Investigator: Stephen S Gottlieb University of Maryland, College Park

Layout table for additonal information
Responsible Party: Steve Gottlieb, Professor of Medicine, University of Maryland, College Park Identifier: NCT03810417     History of Changes
Other Study ID Numbers: HP-00083553
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Steve Gottlieb, University of Maryland, College Park:
coronary artery bypass surgery
acute kidney injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents