Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery (BE-KIND)

University of Maryland Baltimore (UMB)

Status: Not yet enrolling

Conditions: Acute Kidney Injury; Renal Injury

Treatments: Other: Goal Directed Fluid Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06109714

HP-00100950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ACUMEN guided resuscitation protocol

Experimental group

Description:

Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.

Treatment:

Other: Goal Directed Fluid Therapy

Standard of care resuscitation

No Intervention group

Description:

Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography).