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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06109714

Acronym

BE-KIND

Enrollment

100

Registered

2023-10-31

Start date

2026-04-01

Completion date

2029-12-31

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Injury, Acute Kidney Injury

Keywords

Cardiac Surgery, Cardiac Surgery Induced Kidney Injury, Kidney Biomarkers

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.

Interventions

OTHERGoal Directed Fluid Therapy

Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Hemodynamic Support Usage	During the first 48 hours postoperatively	Vasopressor or Inotrope usage
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

Contacts

CONTACTReney A Henderson, MD

rhenderson@som.umaryland.edu4103283961

CONTACTLaToya Stubbs

lstubbs@som.umaryland.edu4103289951

PRINCIPAL_INVESTIGATORReney A Henderson, MD

University of Maryland, Baltimore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026