Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Digoxin Antibodies Fab Fragments
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients undergoing coronary artery bypass surgery
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digifab<br>Digifab intravenous | Drug: Digoxin Antibodies Fab Fragments<br>* Digoxin antibodies<br>|
| Placebo Comparator: Placebo<br>saline intravenous | Other: Placebo<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for dialysis | Number of patients with any dialysis given within 30 days of surgery | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass surgery, ouabain, acute kidney injury