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Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure

Use of an Intraabdominal Pressure Monitoring Urinary Catheter After Cardiac Surgery to Improve Kidney Perfusion Pressure: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06989762
Enrollment
100
Registered
2025-05-25
Start date
2025-08-01
Completion date
2027-10-01
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Intra-Abdominal Pressure, Renal Perfusion Pressure, Cardiac Surgery

Brief summary

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.

Interventions

DEVICEConventional Foley Catheter(Medline)

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.

DEVICEAccuryn Foley Catheter

The Accuryn Foley Catheter is an FDA-approved urinary catheter with continuous intra-abdominal pressure (IAP) monitoring capability.

Sponsors

Dang Tan Phat
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults Undergoing cardiac surgery with cardiopulmonary bypass * Left ventricular ejection fraction (LVEF) \< 50%

Exclusion criteria

* Current pregnancy * ESRD or AKI on dialysis * Currently on ECMO or Impella * Emergent surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO CriteriaPerioperative.Acute Kidney Injury will be defined using the KDIGO criteria: an increase in serum creatinine by ≥0.3 mg/dL within 48 hours or an increase to ≥1.5 times the baseline.

Secondary

MeasureTime frameDescription
ICU Length of StayPerioperativeThe number of days from the day of surgery until discharge from the ICU
Hospital Length of StayPerioperativeThe number of days from the day of surgery until discharge from the hospital (including both ICU and general ward)

Countries

United States

Contacts

Primary ContactPhat T Dang, MD
ptdang@uci.edu714-719-6652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026