Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status and phase

Enrolling
Phase 4

Conditions

Acute Kidney Injury

Treatments

Other: Placebo
Drug: Digoxin Antibodies Fab Fragments

Study type

Interventional

Funder types

Other

Identifiers

NCT03810417
HP-00083553

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

250 participants in 2 patient groups, including a placebo group

Digifab
Active Comparator group
Description:
Digifab intravenous
Treatment:
Drug: Digoxin Antibodies Fab Fragments
Placebo
Placebo Comparator group
Description:
saline intravenous
Treatment:
Other: Placebo

Trial contacts and locations

0

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Central trial contact

Stephen Gottlieb, MD

Data sourced from clinicaltrials.gov

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