Clinical trial NCT06989762: Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure
Official title: Use of an Intraabdominal Pressure Monitoring Urinary Catheter After Cardiac Surgery to Improve Kidney Perfusion Pressure: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Intra-Abdominal Pressure
Renal Perfusion Pressure
Cardiac Surgery
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria
timeFrame: Perioperative.
Secondary outcomes:
measure: ICU Length of Stay
timeFrame: Perioperative
measure: Hospital Length of Stay
timeFrame: Perioperative
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Medical Center
state: California
Study officials:
References:
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citation: Sun J, Sun H, Sun Z, Yang X, Zhou S, Wei J. Intra-abdominal hypertension and increased acute kidney injury risk: a systematic review and meta-analysis. J Int Med Res. 2021 May;49(5):3000605211016627. doi: 10.1177/03000605211016627.
citation: Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.
citation: Engelman DT, Schwann TA. Commentary: A little is way too much: What we have learned about perioperative acute kidney injury. J Thorac Cardiovasc Surg. 2021 Jul;162(1):153-154. doi: 10.1016/j.jtcvs.2019.12.100. Epub 2020 Jan 21. No abstract available.
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citation: Dang PT, Lopez BE, Togashi K. A Decrease in Effective Renal Perfusion Pressure Is Associated With Increased Acute Kidney Injury in Patients Undergoing Cardiac Surgery. Cureus. 2023 Sep 11;15(9):e45036. doi: 10.7759/cureus.45036. eCollection 2023 Sep.