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

Sponsor
University of Maryland, Baltimore
Study ID
NCT06109714
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Renal Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Goal Directed Fluid Therapy — OTHER
    Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor

Study Details

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.

Key Dates

First listed
Oct 31, 2023
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: ACUMEN guided resuscitation protocol
    Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.
  • No Intervention: Standard of care resuscitation
    Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography).

Primary Outcome Measure

Acute Kidney Injury [ Time Frame: 7 days or discharge whichever occurs first ]

Central Contacts

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