Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure
NCT ID: NCT06989762
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-01
2027-10-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Conventional 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.
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).
Accuryn Foley Catheter
The Accuryn Foley Catheter is an FDA-approved urinary catheter with continuous intra-abdominal pressure (IAP) monitoring capability.
Interventions
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Conventional 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.
Accuryn Foley Catheter
The Accuryn Foley Catheter is an FDA-approved urinary catheter with continuous intra-abdominal pressure (IAP) monitoring capability.
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction (LVEF) \< 50%
Exclusion Criteria
* ESRD or AKI on dialysis
* Currently on ECMO or Impella
* Emergent surgery
18 Years
ALL
No
Sponsors
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Dang Tan Phat
OTHER
Responsible Party
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Dang Tan Phat
Assistant Clinical Professor, Department of Anesthesiology & Perioperative Care, University of California, Irvine
Locations
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UCI Medical Center
Irvine, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2756
Identifier Type: -
Identifier Source: org_study_id
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