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

Not Applicable

Not yet recruiting

• Conditions: Renal Injury; Acute Kidney Injury
• Interventions: Other: Goal Directed Fluid Therapy

• Registration Number: NCT06109714
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Study Start: 2025-09-01
• Primary Completion: 2028-04-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACUMEN guided resuscitation protocol	Goal Directed Fluid Therapy	Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	7 days or discharge whichever occurs first	KIDIGO Criteria for AKI
Renal Biomarkers	48 hours postoperatively	NGAL, Hepcidin-25, and Uromodulin

Secondary Outcome Measures

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