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NCT Number: NCT06109714

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

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.

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Key information

Conditions

Renal Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal directed fluid therapy

Other

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

Primary outcomes

  1. Acute Kidney Injury

    Time frame: 7 days or discharge whichever occurs first

    KIDIGO Criteria for AKI

  2. Renal Biomarkers

    Time frame: 48 hours postoperatively

    NGAL, Hepcidin-25, and Uromodulin

Secondary outcomes

  1. Total Fluid Administered

    Time frame: From initiation of surgery to 48 hours postoperatively

    intraoperative and postoperative volume given measured in milliliters

  2. ICU Length of Stay

    Time frame: From admission to the intensive care unit until discharge or 20 weeks whichever comes first.

    Quantified in days and hours

  3. Hemodynamic Support Usage

    Time frame: During the first 48 hours postoperatively

    Vasopressor or Inotrope usage

  4. Morbidity and Mortality

    Time frame: 30 days

    Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours)

  5. Blood Transfusions

    Time frame: From surgical incision to 48 hours postoperatively

    Any Allogeneic Blood Transfusions

Study contacts

Contact information is provided by the study sponsor or research team.

LaToya Stubbs

CONTACT

[email protected]

4103289951

Reney A Henderson, MD

CONTACT

[email protected]

4103283961

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Acronym: BE-KIND

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Oct 31, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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