Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Foley Catheter(Medline), Accuryn Foley Catheter.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of an Intraabdominal Pressure Monitoring Urinary Catheter After Cardiac Surgery to Improve Kidney Perfusion Pressure: A Randomized Controlled Trial
Overview
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
- Device 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. - Device Accuryn Foley Catheter
The Accuryn Foley Catheter is an FDA-approved urinary catheter with continuous intra-abdominal pressure (IAP) monitoring capability.
Primary outcome measures
- Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria [Time frame: Perioperative.]
Secondary outcome measures (2)
- ICU Length of Stay [Time frame: Perioperative]
- Hospital Length of Stay [Time frame: Perioperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UCI Medical Center — Irvine
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06989762 · 2756