Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure

NCT06989762 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2756
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Perioperative.

Secondary Outcomes (2)

• ICU Length of Stay

  Perioperative

• Hospital Length of Stay

  Perioperative

Study Arms (2)

Control Group - Standard ICU Care with Conventional Foley

ACTIVE COMPARATOR

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.

Device: Conventional Foley Catheter(Medline)

Intervention Group - IAP Monitoring and Renal Perfusion Pressure Optimization

EXPERIMENTAL

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).

Device: Accuryn Foley Catheter

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.

Control Group - Standard ICU Care with Conventional Foley

Accuryn Foley Catheter DEVICE

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

Intervention Group - IAP Monitoring and Renal Perfusion Pressure Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dang Tan Phat: lead

Study Sites (1)

UCI Medical Center

Irvine, California, 92868, United States

Location

Related Publications (10)

• Chen SS, Chen WC, Hayakawa S, Li PC, Chien CT. Acute urinary bladder distension triggers ICAM-1-mediated renal oxidative injury via the norepinephrine-renin-angiotensin II system in rats. J Formos Med Assoc. 2009 Aug;108(8):627-35. doi: 10.1016/s0929-6646(09)60383-1.

  PMID: 19666350 BACKGROUND

• Hertzberg D, Sartipy U, Lund LH, Ryden L, Pickering JW, Holzmann MJ. Heart failure and the risk of acute kidney injury in relation to ejection fraction in patients undergoing coronary artery bypass grafting. Int J Cardiol. 2019 Jan 1;274:66-70. doi: 10.1016/j.ijcard.2018.09.092. Epub 2018 Sep 28.

  PMID: 30297189 BACKGROUND

• Gao Y, Wang C, Li J, Ji B, Wang J, Yan F, Wang Y. Mild and moderate to severe early acute kidney injury following cardiac surgery among patients with heart failure and preserved vs. mid-range vs. reduced ejection fraction: A retrospective cohort study. Eur J Anaesthesiol. 2022 Aug 1;39(8):673-684. doi: 10.1097/EJA.0000000000001713. Epub 2022 Jul 5.

  PMID: 35791895 BACKGROUND

• Kopitko C, Medve L, Gondos T. The value of combined hemodynamic, respiratory and intra-abdominal pressure monitoring in predicting acute kidney injury after major intraabdominal surgeries. Ren Fail. 2019 Nov;41(1):150-158. doi: 10.1080/0886022X.2019.1587467.

  PMID: 30909772 BACKGROUND

• Dalfino L, Sicolo A, Paparella D, Mongelli M, Rubino G, Brienza N. Intra-abdominal hypertension in cardiac surgery. Interact Cardiovasc Thorac Surg. 2013 Oct;17(4):644-51. doi: 10.1093/icvts/ivt272. Epub 2013 Jul 2.

  PMID: 23820668 BACKGROUND

• 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.

  PMID: 34053324 BACKGROUND

• 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.

  PMID: 19398670 BACKGROUND

• 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.

  PMID: 32061391 BACKGROUND

• Priyanka P, Zarbock A, Izawa J, Gleason TG, Renfurm RW, Kellum JA. The impact of acute kidney injury by serum creatinine or urine output criteria on major adverse kidney events in cardiac surgery patients. J Thorac Cardiovasc Surg. 2021 Jul;162(1):143-151.e7. doi: 10.1016/j.jtcvs.2019.11.137. Epub 2020 Jan 9.

  PMID: 32033818 BACKGROUND

• 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.

  PMID: 37829983 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Phat T Dang, MD

CONTACT

714-719-6652; ptdang@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor, Department of Anesthesiology & Perioperative Care, University of California, Irvine

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)