Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Recruiting

CT.gov ID

NCT03810417

Collaborator

(none)

250

Enrollment

Locations

Arms

40.3

Anticipated Duration (Months)

125

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Digoxin Antibodies Fab Fragments Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients undergoing coronary artery bypass surgeryPatients undergoing coronary artery bypass surgery

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Investigational pharmacy will provide active drug or placebo

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jul 22, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Digifab Digifab intravenous	Drug: Digoxin Antibodies Fab Fragments Digoxin antibodies
Placebo Comparator: Placebo saline intravenous	Other: Placebo Saline

Arm

Intervention/Treatment

Active Comparator: Digifab

Digifab intravenous

Drug: Digoxin Antibodies Fab Fragments

Digoxin antibodies

Placebo Comparator: Placebo

saline intravenous

Other: Placebo

Saline

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Need for dialysis [30 days]
Number of patients with any dialysis given within 30 days of surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland	Baltimore	Maryland	United States	21201
2	St Josephs Medical Center	Baltimore	Maryland	United States	21204

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

Principal Investigator: Stephen S Gottlieb, University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Gottlieb, Professor of Medicine, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT03810417

Other Study ID Numbers:

HP-00083553

First Posted:

Jan 18, 2019

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Stephen Gottlieb, Professor of Medicine, University of Maryland, Baltimore

coronary artery bypass surgery

ouabain

acute kidney injury

Additional relevant MeSH terms:

Acute Kidney Injury

Digoxin

Antibodies

Immunoglobulin Fab Fragments

Study Results

No Results Posted as of Jan 5, 2022