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Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Primary Purpose

Acute Kidney Injury

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Digoxin Antibodies Fab Fragments
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring coronary artery bypass surgery, ouabain, acute kidney injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MarylandRecruiting
  • St Josephs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Digifab

Placebo

Arm Description

Digifab intravenous

saline intravenous

Outcomes

Primary Outcome Measures

Renal function
Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2

Secondary Outcome Measures

Need for dialysis
Number of patients with any dialysis given within 30 days of surgery

Full Information

First Posted
January 8, 2019
Last Updated
March 8, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03810417
Brief Title
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
coronary artery bypass surgery, ouabain, acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients undergoing coronary artery bypass surgery
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigational pharmacy will provide active drug or placebo
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digifab
Arm Type
Active Comparator
Arm Description
Digifab intravenous
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline intravenous
Intervention Type
Drug
Intervention Name(s)
Digoxin Antibodies Fab Fragments
Intervention Description
Digoxin antibodies
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Renal function
Description
Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Need for dialysis
Description
Number of patients with any dialysis given within 30 days of surgery
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Gottlieb, MD
Phone
4103288788
Email
sgottlie@medicine.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen S Gottlieb
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Gottlieb, MD
Phone
410-328-8788
Email
sgottlie@medicine.umaryland.edu
Facility Name
St Josephs Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Gottlieb
Phone
410-328-8788
Email
sgottlie@medicine.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

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