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

March 13, 2026 updated by: Reney Henderson, University of Maryland, Baltimore
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Reney A Henderson, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00100950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Kidney Injury

Clinical Trials on Goal Directed Fluid Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe