Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure

Part of paid clinical trials in Irvine, California.

Sponsor
Dang Tan Phat
Study ID
NCT06989762
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Foley Catheter(Medline) — DEVICE
    The Conventional Foley Catheter is a standard urinary catheter used in ICU care to monitor urine output. It does not have intra-abdominal pressure (IAP) monitoring capabilities.
  • Accuryn Foley Catheter — DEVICE
    The Accuryn Foley Catheter is an FDA-approved urinary catheter with continuous intra-abdominal pressure (IAP) monitoring capability.

Study Details

The goal of this clinical trial is to determine whether monitoring intra-abdominal pressure (IAP) and adjusting blood pressure accordingly to maintain optimal renal perfusion pressure can reduce the risk of acute kidney injury (AKI) after cardiac surgery. The main question this study aims to answer is: \- Does IAP-guided blood pressure management improve renal perfusion and lower AKI rates in cardiac surgery patients? Participants will be randomly assigned to one of two groups: * Control Group: Standard ICU care with a conventional Foley catheter. * Intervention Group: Standard ICU care with an IAP-monitoring Foley catheter, where blood pressure is adjusted based on IAP readings to optimize renal perfusion pressure. All participants will undergo routine blood and urine tests to assess kidney function during their hospital stay. This study will help determine whether IAP-based hemodynamic management can improve postoperative kidney outcomes and provide a new strategy for AKI prevention in cardiac surgery patients.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2025
Primary completion
Jun 1, 2027
Completion
Oct 1, 2027

Study Design

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

Arms

  • Active Comparator: Control Group - Standard ICU Care with Conventional Foley
    Participants will receive standard ICU care after cardiac surgery with a conventional Foley catheter. Blood pressure management will follow routine ICU protocols without intra-abdominal pressure (IAP) monitoring.
  • Experimental: Intervention Group - IAP Monitoring and Renal Perfusion Pressure Optimization
    Participants will receive standard ICU care after cardiac surgery with an IAP-monitoring Foley catheter. Blood pressure will be adjusted based on IAP readings to optimize renal perfusion pressure(41mmHg).

Primary Outcome Measure

Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria [ Time Frame: Perioperative. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCI Medical CenterIrvineCalifornia92868
Phat T Dang, MD
[email protected]

Find similar trials in Irvine, CA

By research site
UCI Medical Center· Irvine, CA

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