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Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

NCT ID: NCT03810417

Last Updated: 2025-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients undergoing coronary artery bypass surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Investigational pharmacy will provide active drug or placebo

Study Groups

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Digifab, EO > 360

Digifab intravenous in subject with baseline ouabain concentration \> 360 pm

Group Type ACTIVE_COMPARATOR

Digoxin Antibodies Fab Fragments

Intervention Type DRUG

Digoxin antibodies

Baseline EO > 360 pM

Intervention Type DIAGNOSTIC_TEST

Baseline ouabain concentration \> 360 pM

Placebo, EO > 360

saline intravenous n subject with baseline ouabain concentration \> 360 pm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Baseline EO > 360 pM

Intervention Type DIAGNOSTIC_TEST

Baseline ouabain concentration \> 360 pM

Digifab, EO < 360

Digifab in subject with baseline ouabain concentration \< 360 pm

Group Type ACTIVE_COMPARATOR

Digoxin Antibodies Fab Fragments

Intervention Type DRUG

Digoxin antibodies

EO < 360 pM

Intervention Type DIAGNOSTIC_TEST

Baseline ouabain concentration \< 360 pM

Placebo, EO < 360

Subjects who received Placebo in n subject with baseline ouabain concentration \< 360 pm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

EO < 360 pM

Intervention Type DIAGNOSTIC_TEST

Baseline ouabain concentration \< 360 pM

Interventions

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Digoxin Antibodies Fab Fragments

Digoxin antibodies

Intervention Type DRUG

Placebo

Saline

Intervention Type OTHER

Baseline EO > 360 pM

Baseline ouabain concentration \> 360 pM

Intervention Type DIAGNOSTIC_TEST

EO < 360 pM

Baseline ouabain concentration \< 360 pM

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Stephen Gottlieb

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen S Gottlieb

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

St Josephs Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HP-00083553

Identifier Type: -

Identifier Source: org_study_id

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