Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810417
• Other study ID #: HP-00083553
• Status: Completed
• Phase: Phase 4
• Start date: July 22, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Digoxin Antibodies Fab Fragments
Digoxin antibodies

Other:
• Placebo
Saline

Locations

Country	Name	City	State
United States	St Josephs Medical Center	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2	72 hours
Secondary	Need for dialysis	Number of patients with any dialysis given within 30 days of surgery	30 days