Health TrialsbyHealthPanel

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

ConditionsRenal InjuryAcute Kidney Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients undergoing cardiopulmonary bypass

Procedure coronary artery bypass grafting, aortic valve replacement, or both

Disqualifiers

Patients < 18 years old

Emergent surgery

Preoperative kidney disease (Cr > 2.0 or on renal replacement therapy)

Ejection fraction < 40%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Goal Directed Fluid Therapy

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ACUMEN guided resuscitation protocolExperimental treatment 1 intervention
Group B: Standard of care resuscitationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Acute Kidney Injury

KIDIGO Criteria for AKI

Time frame
7 days or discharge whichever occurs first
2

Renal Biomarkers

NGAL, Hepcidin-25, and Uromodulin

Time frame
48 hours postoperatively

Secondary outcomes

1

Total Fluid Administered

intraoperative and postoperative volume given measured in milliliters

Time frame
From initiation of surgery to 48 hours postoperatively
2

ICU Length of Stay

Quantified in days and hours

Time frame
From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
3

Hemodynamic Support Usage

Vasopressor or Inotrope usage

Time frame
During the first 48 hours postoperatively
4

Morbidity and Mortality

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

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: