Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Digoxin Antibodies Fab Fragments; Other: Placebo

• Registration Number: NCT03810417
• Lead Sponsor: University of Maryland, Baltimore

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 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

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 Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-07-22
• Status Verified: 2024-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digifab	Digoxin Antibodies Fab Fragments	Digifab intravenous
Placebo	Placebo	saline intravenous

Primary Outcome Measures

Name	Time	Method
Renal function	72 hours	Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2

Secondary Outcome Measures

Name	Time	Method
Need for dialysis	30 days	Number of patients with any dialysis given within 30 days of surgery

Trial Locations

Locations (2)

St Josephs Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States