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Completed

NCT Number: NCT03810417

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

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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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Josephs Medical Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digoxin Antibodies Fab Fragments

Drug

Digoxin antibodies

Placebo

Other

Saline

Baseline EO > 360 pM

Diagnostic Test

Baseline ouabain concentration > 360 pM

EO < 360 pM

Diagnostic Test

Baseline ouabain concentration < 360 pM

Primary outcomes

  1. Renal Function

    Time frame: 72 hours

    Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours

Secondary outcomes

  1. AKI

    Time frame: 3 days

    Development of AKI at 72 hours

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2019
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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