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AzTrials

Acute Kidney InjuryNCT06989762

Intraabdominal Pressure Monitoring Urinary Catheter and Kidney Perfusion Pressure

A study testing Conventional Foley Catheter(Medline) and Accuryn Foley Catheter in people with Acute Kidney Injury, run by Dang Tan Phat at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
Conventional Foley Catheter(Medline) and Accuryn Foley Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Aug 2025to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Phat T Dang, MD contact

714-719-6652

ptdang@uci.edu

United States1 site

  • UCI Medical Center

    Irvine, California, 92868

    Phat T Dang, MD, ptdang@uci.edu

Other trials in United States

About this study

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

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:

Read more
  • 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.

Being tested
Conventional Foley Catheter(Medline), Accuryn Foley Catheter
Keywords
Acute Kidney Injury, Intra-Abdominal Pressure, Renal Perfusion Pressure, Cardiac Surgery
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 CatheterDevice

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

Study groups in NCT06989762
Study groupRoleWhat they receive
Control Group - Standard ICU Care with Conventional FoleyActive comparatorParticipants 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.
Receives: Device: Conventional Foley Catheter(Medline)
Intervention Group - IAP Monitoring and Renal Perfusion Pressure OptimizationExperimentalParticipants 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).
Receives: Device: Accuryn Foley Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Perioperative.

Secondary outcomes (2)

  1. ICU Length of Stay

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

    Measured: Perioperative

  2. Hospital Length of Stay

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

    Measured: Perioperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06989762
Sponsor's protocol ID
2756
Status last verified
Apr 2025
First submitted
15 Apr 2025
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: The IPB will be kept for this study only. Will not share with any other study

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32061391

  • 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.

    PubMed 32033818

  • 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.

    PubMed 37829983

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Foley Catheter(Medline) and Accuryn Foley Catheter in people with Acute Kidney Injury, run by Dang Tan Phat at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phat T Dang, MD (714-719-6652, ptdang@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria (time frame: Perioperative.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06989762, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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