Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

University of Maryland Baltimore (UMB)

Status and phase: Completed; 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 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

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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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