Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

Study Overview
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Brief Summary
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This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.

Detailed Description
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This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients undergoing a CABG, AVR, or CABG/AVR. Kidney injury biomarkers NGAL, Uromodulin, and Hepcidin-25 will be used to assess cardiac-induced kidney injury. Patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with ACUMEN.

Official Title
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

Conditions
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Renal Injury, Acute Kidney Injury

Intervention / Treatment
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* Other: Goal Directed Fluid Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing cardiopulmonary bypass Procedure coronary artery bypass grafting, aortic valve replacement, or both Exclusion Criteria: Patients < 18 years old Emergent surgery Preoperative kidney disease (Cr > 2.0 or on renal replacement therapy) Ejection fraction < 40% Incomplete data in medical record

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACUMEN guided resuscitation protocol<br>Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol. | Other: Goal Directed Fluid Therapy<br>* Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor<br>|
| No Intervention: Standard of care resuscitation<br>Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | KIDIGO Criteria for AKI | 7 days or discharge whichever occurs first | 
| Renal Biomarkers | NGAL, Hepcidin-25, and Uromodulin | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Fluid Administered | intraoperative and postoperative volume given measured in milliliters | From initiation of surgery to 48 hours postoperatively | 
| ICU Length of Stay | Quantified in days and hours | From admission to the intensive care unit until discharge or 20 weeks whichever comes first. | 
| Hemodynamic Support Usage | Vasopressor or Inotrope usage | During the first 48 hours postoperatively | 
| Morbidity and Mortality | Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours) | 30 days | 
| Blood Transfusions | Any Allogeneic Blood Transfusions | From surgical incision to 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Cardiac Surgery Induced Kidney Injury, Kidney Biomarkers