DigiFab for Preventing Kidney Injury After Heart Surgery
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Digoxin Antibodies Fab Fragments for preventing kidney injury after heart surgery?
Digoxin-specific antibody fragments (digoxin-Fab) are known to be effective in treating digoxin poisoning by binding to the drug and allowing it to be safely removed from the body, which suggests they might help in managing drug-related kidney issues by reducing the active drug levels in the body.12345
Is DigiFab safe for use in humans?
How is the drug DigiFab unique in preventing kidney injury after heart surgery?
DigiFab, a digoxin-specific antibody fragment, is unique because it binds to digoxin and similar molecules, allowing for their rapid removal from the body through the kidneys. This mechanism, originally used to treat digoxin poisoning, may help prevent kidney injury by reducing the toxic effects of digoxin-like substances on the kidneys.2391011
What is the purpose of this trial?
This trial is testing DigiFab, a medication that may lower harmful substance levels in the blood, in patients undergoing heart surgery who are at high risk for kidney damage. By reducing these levels, DigiFab could help protect the kidneys from damage.
Research Team
Stephen S Gottlieb
Principal Investigator
University of Maryland
Eligibility Criteria
This trial is for patients who are about to have coronary artery bypass surgery and either have diabetes or a glomerular filtration rate (GFR) less than 60, but above 15. It's not for those allergic to Digifab, recently exposed to contrast dye, or with creatinine levels more than 25% above their baseline.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Treatment
Participants receive DigiFab or placebo intravenously before undergoing CABG surgery
Post-operative Follow-up
Participants are monitored for acute kidney injury and renal function for 72 hours after CABG surgery
Extended Follow-up
Participants are monitored for the need for dialysis within 30 days of surgery
Treatment Details
Interventions
- Digoxin Antibodies Fab Fragments
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor