Ignite Creation Date:
2024-05-06 @ 12:38 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03810417
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2019-01-08
Brief Title:
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 highThere 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None