Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

  • STATUS
    Recruiting
  • End date
    Dec 4, 2021
  • participants needed
    250
  • sponsor
    University of Maryland, Baltimore
Updated on 4 November 2020
Investigator
Stephen Gottlieb, MD
Primary Contact
St Josephs Medical Center (9.3 mi away) Contact
+1 other location
diabetes
glomerular filtration rate
renal injury
heart surgery
dialysis
coronary artery bypass graft

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.

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.

Details
Treatment Placebo, Digoxin Antibodies Fab Fragments
Clinical Study IdentifierNCT03810417
SponsorUniversity of Maryland, Baltimore
Last Modified on4 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Failure (Pediatric) or Renal Failure or Kidney Failure or Acute renal failure?
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
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