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Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

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ClinicalTrials.gov Identifier: NCT03810417
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland

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.

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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
Estimated Study Start Date : September 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
Saline




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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03810417


Contacts
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Contact: Stephen Gottlieb, MD 4103288788 sgottlie@medicine.umaryland.edu

Sponsors and Collaborators
University of Maryland
Investigators
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Principal Investigator: Stephen S Gottlieb University of Maryland

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Responsible Party: Steve Gottlieb, Professor of Medicine, University of Maryland
ClinicalTrials.gov Identifier: NCT03810417     History of Changes
Other Study ID Numbers: HP-00083553
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
coronary artery bypass surgery
ouabain
acute kidney injury

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antibodies
Immunoglobulin Fab Fragments
Digoxin
Ouabain
Immunologic Factors
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents