Clinical Trials Logo
  1. Home
  2. Acute Kidney Injury
  3. NCT03810417

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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03810417
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Completed
Phase Phase 4
Start date July 22, 2019
Completion date April 30, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05538351 - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03938038 - Guidance of Ultrasound in Intensive Care to Direct Euvolemia N/A
Recruiting NCT05805709 - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial N/A
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting NCT05897840 - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients N/A
Recruiting NCT04986137 - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Terminated NCT04293744 - Acute Kidney Injury After Cardiac Surgery N/A
Completed NCT04095143 - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting NCT06064305 - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated NCT03438877 - Intensive Versus Regular Dosage For PD In AKI. N/A
Terminated NCT03305549 - Recovery After Dialysis-Requiring Acute Kidney Injury N/A
Completed NCT05990660 - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery N/A
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated NCT02860130 - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT) Phase 3
Completed NCT06000098 - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting NCT05548725 - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed NCT02665377 - Prevention of Akute Kidney Injury, Hearttransplant, ANP Phase 3
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A