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NCT Number: NCT06989762

Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Medical Center

Irvine, California, 92868, United States

Location contact

Phat T Dang, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria

    Time frame: Perioperative.

    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 outcomes

  1. ICU Length of Stay

    Time frame: Perioperative

    The number of days from the day of surgery until discharge from the ICU

  2. Hospital Length of Stay

    Time frame: Perioperative

    The number of days from the day of surgery until discharge from the hospital (including both ICU and general ward)

Study contacts

Contact information is provided by the study sponsor or research team.

Phat T Dang, MD

CONTACT

[email protected]

714-719-6652

Sponsors and collaborators

Lead sponsor

Dang Tan Phat

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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