AKI - Acute Kidney InjuryPRESERVE-CABGNCT07085286
Perfusion Related Evaluation of Systemic and Renal Vulnerability to Events in CABG
An observational study of AKI - Acute Kidney Injury and CABG, run by Medical University of Lublin.
Trial summary
The goal of this observational study is to learn whether high abdominal pressure or low blood flow pressure to the kidneys is linked to kidney injury after heart surgery. The main questions it aims to answer are: Does high abdominal pressure increase the risk of kidney injury after cardiac surgery? Can low blood flow… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury, CABG
- What is being tested?
- Continous IAP measurement
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: This two-center prospective observational study will enroll adult patients undergoing cardiac surgery (e.g., coronary artery bypass grafting, valve surgery, or assist device placement). Participants will receive a TraumaGuard urinary catheter, which functions both as a standard Foley catheter and as a device for continuous intra-abdominal pressure monitoring. Data will be collected during and after surgery. An initial cohort of 45 patients will be analyzed for feasibility and to inform the sample size for future enrollment.
Who may be able to join
- Age 18 years or older
- Undergoing cardiac surgery (CABG, valve surgery, combined procedures, heart transplantation, or placement of assist device)
- Expected hospital stay of at least one night
- Preoperative serum creatinine measurement available
- At least one postoperative serum creatinine measurement available
Who cannot join
- Age below 18 years
- Incarcerated individuals
- No requirement for urinary catheter placement
- Presence of a do-not-resuscitate (DNR) order
- Pregnant or lactating individuals
- Fewer than 12 hours of recorded data (including intraoperative data)
- No informed consent (if a waiver is not granted)
- Pre-existing chronic kidney disease, defined as estimated glomerular filtration rate <60 mL/min/1.73 m²
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prognostic Value of Continuous Intra-abdominal Pressure (CIAP) and Continuous Abdominal Perfusion Pressure (CAPP) Monitoring for Acute Kidney Injury (AKI) Prediuction in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
The goal of this observational study is to learn whether high abdominal pressure or low blood flow pressure to the kidneys is linked to kidney injury after heart surgery. The main questions it aims to answer are:
Does high abdominal pressure increase the risk of kidney injury after cardiac surgery?
Read more
Can low blood flow pressure to the kidneys help predict who may develop kidney problems?
Participants in this study are adults undergoing heart surgery, such as coronary artery bypass grafting (CABG) or valve surgery. Researchers will measure abdominal pressure and blood pressure continuously before and after surgery using medical devices that are already part of routine care. This study does not involve any changes to standard treatment.
Participants will:
Have their abdominal and blood pressures continuously monitored using existing devices
Have blood and urine tests to check kidney function
Be followed during their hospital stay and up to 30 days after surgery to assess outcomes like length of stay, readmission, and survival
This study takes place at two hospitals-one in Poland and one in the United States. Researchers hope the findings will help identify early warning signs of kidney injury and improve monitoring practices after heart surgery.
Read the detailed description
This is a prospective, observational pilot study designed to investigate the relationship between elevated intra-abdominal pressure (IAP), impaired perfusion pressures, and the development of acute kidney injury (AKI) in adult patients undergoing cardiac surgery. The study will focus on whether continuous intra-abdominal pressure (CIAP) monitoring can provide early warning signs for AKI and other postoperative complications.
Intra-abdominal pressure (IAP) refers to the steady-state pressure within the abdominal cavity. In healthy individuals, IAP typically ranges between 5 and 7 millimeters of mercury (mmHg), while values may rise to around 10 mmHg in critically ill patients. Sustained IAP values at or above 12 mmHg define intra-abdominal hypertension (IAH). More severe elevations above 20 mmHg can result in abdominal compartment syndrome (ACS), which is associated with new organ dysfunction or failure. IAH can negatively impact multiple organ systems, including the kidneys, lungs, cardiovascular system, gastrointestinal tract, liver, and brain, through both mechanical and biochemical mechanisms.
Traditional IAP monitoring methods rely on intermittent measurement via the urinary bladder using a Foley catheter and saline instillation, performed at end-expiration with the patient in the supine position. Although this method is widely accepted, it is labor-intensive, operator-dependent, and cannot provide real-time pressure trends. As a result, diagnosis and management of IAH may be delayed.
Advancements in monitoring technology now allow for continuous IAP measurement using devices such as the TraumaGuard catheter. This dual-balloon Foley catheter provides real-time data on both IAP and core body temperature. It connects to standard intensive care unit (ICU) bedside monitors and allows continuous data capture and analysis.
This study will use continuous measurements of IAP, mean arterial pressure (MAP), central venous pressure (CVP), and mean alveolar pressure (Palv) to calculate key perfusion pressures:
Abdominal perfusion pressure (APP) = MAP - IAP
Mean perfusion pressure (MPP) = MAP - CVP
Renal perfusion pressure (RPP):
- In patients not receiving mechanical ventilation: RPP = MAP - IAP - CVP
- In mechanically ventilated patients: RPP = MAP - IAP - CVP - Palv
Continuous monitoring will also allow for the calculation of area under the curve (AUC) and time above threshold (TAT), providing a dynamic view of the pressure-time burden and potentially offering earlier insight into evolving complications. These data will be analyzed to assess whether sustained periods of low APP, MPP, or RPP are associated with higher rates of AKI and other adverse outcomes.
Cardiac surgery patients are considered at high risk for IAH due to fluid shifts, systemic inflammation, positive pressure ventilation, and reduced abdominal wall compliance. This study will capture multiple IAH risk factors, including patient demographics (e.g., obesity, body mass index, age), surgical variables (e.g., cardiopulmonary bypass duration, transfusion volume), and clinical factors (e.g., presence of sepsis, acidosis, or coagulopathy).
All participants will receive standard-of-care monitoring, including urinary catheters and arterial lines. The TraumaGuard catheter will be used only for data collection purposes and will not influence clinical management. No deviation from routine practice is required, and the study is entirely observational in nature.
The primary outcome is the incidence of acute kidney injury (AKI), diagnosed using Kidney Disease: Improving Global Outcomes (KDIGO) criteria. AKI will be identified by changes in serum creatinine levels and reductions in urine output during the first seven postoperative days. Secondary outcomes include myocardial injury, intensive care unit (ICU) and hospital length of stay, 30-day mortality, and hospital readmission.
Perfusion pressures (MAP, APP, MPP, RPP) will be analyzed to determine the duration and depth of hypotension relative to specific thresholds. All data will be collected continuously from bedside monitors and synchronized using timestamps to ensure accuracy. The TraumaGuard data will be integrated with beat-to-beat electronic medical record data (e.g., CapsuleTech or equivalent systems).
A total of 45 adult patients undergoing elective cardiac surgery (CABG or valve surgery) will be enrolled at two academic centers. This sample size is based on previous feasibility data and is expected to generate at least 12 AKI events, sufficient to explore statistical associations, estimate variance, and refine methodology for a larger follow-up study.
Descriptive statistics will be used to summarize perfusion pressures, with group comparisons between patients who develop AKI and those who do not. Receiver operating characteristic (ROC) curve analysis will be conducted to identify thresholds of IAP, APP, MPP, and RPP that predict AKI and other complications. A Kaplan-Meier survival analysis will be used to compare outcomes based on the presence of IAH and low perfusion pressures.
Due to the limited sample size, multivariable regression analysis will not be performed in this pilot phase.
This study aims to determine whether continuous intra-abdominal pressure monitoring can serve as a clinically valuable, noninvasive method for early detection of hemodynamic deterioration and AKI after cardiac surgery. The results may inform the design of larger-scale studies and help evaluate the potential role of IAP monitoring as a new vital sign in critical care.
- Conditions
- AKI - Acute Kidney Injury, CABG
- Being tested
- Continous IAP measurement
- Keywords
- abdominal pressure, IAP, abdominal perfusion pressure, mean perfusion pressure, renal perfusion pressure, prediction, AKI
- 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.
Continous IAP measurementDevice
Continuous IAP measurement via existing Foley bladder catheter - allowing continuous APP, MPP and RPP calculation
| Study group | Role | What they receive |
|---|---|---|
| Patients with postoperative AKI | According to KDIGO criteria Receives: Device: Continous IAP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury (AKI) in participants with and without intra-abdominal hypertension (IAH)
To determine whether the presence of intra-abdominal hypertension (IAP ≥ 12 mmHg) is associated with a higher incidence of AKI follow.
Measure Type: Binary outcome. Unit of Measure: % of participants with AKI. Method of Assessment: AKI will be diagnosed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, based on changes in serum creatinine and urine output. IAH will be defined as intra-abdominal pressure (IAP) ≥ 12 mmHg, measured using continuous intra-abdominal pressure monitoring.
Measured: Postoperative Days 0 through 7
Secondary outcomes (5)
Association between abdominal perfusion pressure (APP) and incidence of acute kidney injury (AKI)
To assess whether lower abdominal perfusion pressure (APP = mean arterial pressure - intra-abdominal pressure) is associated with a higher risk of AKI.
Measure Type: Comparative association. Unit of Measure: Odds ratio for AKI or % of participants with AKI by APP range. Method of Assessment: APP will be calculated using continuously recorded mean arterial pressure (MAP) and intra-abdominal pressure (IAP). AKI will be assessed using KDIGO criteria.
Measured: Postoperative Days 0 through 7
Association between mean perfusion pressure (MPP) and incidence of acute kidney injury (AKI)
To assess whether lower mean perfusion pressure (MPP = mean arterial pressure - central venous pressure) is associated with a higher risk of AKI.
Measure Type: Comparative association. Unit of Measure: Odds ratio for AKI or % of participants with AKI by MPP range. Method of Assessment: MPP will be calculated using continuously recorded mean arterial pressure (MAP) and central venous pressure (CVP). AKI will be assessed using KDIGO criteria.
Measured: Postoperative Days 0 through 7
Association between renal perfusion pressure (RPP) and incidence of acute kidney injury (AKI)
To evaluate whether lower renal perfusion pressure (RPP) is associated with an increased risk of AKI after cardiac surgery.
In non-ventilated patients: RPP = MAP - IAP - CVP
In mechanically ventilated patients: RPP = MAP - IAP - CVP - mean alveolar pressure (Palv) Measure Type: Comparative association. Unit of Measure: Odds ratio for AKI or % of participants with AKI by RPP range. Method of Assessment: RPP will be calculated using continuously recorded mean arterial pressure (MAP), intra-abdominal pressure (IAP), central venous pressure (CVP), and mean alveolar pressure (Palv) where applicable. AKI is defined using KDIGO criteria.
Measured: Postoperative Days 0 through 7
Association between intra-abdominal hypertension (IAH) and postoperative myocardial injury
To evaluate whether participants who develop intra-abdominal hypertension (IAP ≥ 12 mmHg) are more likely to experience myocardial injury after cardiac surgery.
Measure Type: Binary outcome. Unit of Measure: % of participants with myocardial injury. Method of Assessment: Myocardial injury defined by cardiac biomarkers: troponin T ≥ 0.04 µg/L or creatine kinase-MB (CK-MB) ≥ 8.8 ng/mL, measured within 7 days of surgery.
Measured: Postoperative Days 0 through 7
Agreement between intra-abdominal pressure (IAP) measurements using the TraumaGuard device and standard intermittent bladder pressure measurements
To assess the agreement, accuracy, and reliability of intra-abdominal pressure (IAP) monitoring using the TraumaGuard catheter (IAPTG) compared to the gold-standard intermittent transvesical measurement technique. Agreement will be evaluated using statistical measures such as Bland-Altman plots and intraclass correlation coefficients (ICC).
Measure Type: Comparative diagnostic performance. Unit of Measure: Intraclass correlation coefficient (ICC), mean difference (mmHg), limits of agreement (mmHg).
Method of Assessment: Intra-abdominal pressure will be measured simultaneously using both the TraumaGuard catheter system and the intermittent bladder pressure method. Measurements will be recorded at predefined intervals with the patient in supine position. Agreement between methods will be analyzed to determine validity, reproducibility, and potential clinical interc
Measured: Up to 48 hours post-surgery (duration of Foley catheter placement in ICU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Manu Malbrain, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085286
- Sponsor's protocol ID
- MUL_PRESERVE-CABG_001
- Acronym
- PRESERVE-CABG
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Needs to be defined
Publications
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 37829983Goeddel LA, Hernandez M, Koffman L, Murphy Z, Khanna AK, Robich M, Whitman G, Zhou X, Bandeen-Roche K, Muschelli J 3rd, Parikh CR, Lima JAC, Crainiceanu CM, Brown C 4th, Faraday N. Fine-Mapping the Association of Acute Kidney Injury With Mean Arterial and Central Venous Pressures During Coronary Artery Bypass Surgery. Anesth Analg. 2025 Jun 1;140(6):1439-1449. doi: 10.1213/ANE.0000000000007500. Epub 2025 Apr 17.
PubMed 40244889Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Kopitko 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 30909772Cheatham ML, White MW, Sagraves SG, Johnson JL, Block EF. Abdominal perfusion pressure: a superior parameter in the assessment of intra-abdominal hypertension. J Trauma. 2000 Oct;49(4):621-6; discussion 626-7. doi: 10.1097/00005373-200010000-00008.
PubMed 11038078Panwar R, Tarvade S, Lanyon N, Saxena M, Bush D, Hardie M, Attia J, Bellomo R, Van Haren F; REACT Shock Study Investigators and Research Coordinators. Relative Hypotension and Adverse Kidney-related Outcomes among Critically Ill Patients with Shock. A Multicenter, Prospective Cohort Study. Am J Respir Crit Care Med. 2020 Nov 15;202(10):1407-1418. doi: 10.1164/rccm.201912-2316OC.
PubMed 32614244Schneider AG, Goodwin MD, Bellomo R. Measurement of kidney perfusion in critically ill patients. Crit Care. 2013 Mar 19;17(2):220. doi: 10.1186/cc12529. No abstract available.
PubMed 23514525Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068.
PubMed 19215833Loutzenhiser R, Griffin K, Williamson G, Bidani A. Renal autoregulation: new perspectives regarding the protective and regulatory roles of the underlying mechanisms. Am J Physiol Regul Integr Comp Physiol. 2006 May;290(5):R1153-67. doi: 10.1152/ajpregu.00402.2005.
PubMed 16603656Malbrain MLNG, Tantakoun K, Zara AT, Ferko NC, Kelly T, Dabrowski W. Urine output is an early and strong predictor of acute kidney injury and associated mortality: a systematic literature review of 50 clinical studies. Ann Intensive Care. 2024 Jul 9;14(1):110. doi: 10.1186/s13613-024-01342-x.
PubMed 38980557Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA; Acute Disease Quality Initiative Workgroup 16.. Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27.
PubMed 28239173O'Neal JB, Shaw AD, Billings FT 4th. Acute kidney injury following cardiac surgery: current understanding and future directions. Crit Care. 2016 Jul 4;20(1):187. doi: 10.1186/s13054-016-1352-z.
PubMed 27373799Han SS, Shin N, Baek SH, Ahn SY, Kim DK, Kim S, Chin HJ, Chae DW, Na KY. Effects of acute kidney injury and chronic kidney disease on long-term mortality after coronary artery bypass grafting. Am Heart J. 2015 Mar;169(3):419-25. doi: 10.1016/j.ahj.2014.12.019. Epub 2015 Jan 6.
PubMed 25728733Drosos G, Ampatzidou F, Sarafidis P, Karaiskos T, Madesis A, Boutou AK. Serum Creatinine and Chronic Kidney Disease-Epidemiology Estimated Glomerular Filtration Rate: Independent Predictors of Renal Replacement Therapy following Cardiac Surgery. Am J Nephrol. 2018;48(2):108-117. doi: 10.1159/000492182. Epub 2018 Aug 15.
PubMed 30110680Chew STH, Hwang NC. Acute Kidney Injury After Cardiac Surgery: A Narrative Review of the Literature. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1122-1138. doi: 10.1053/j.jvca.2018.08.003. Epub 2018 Aug 7.
PubMed 30228051
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Continuous Intra-abdominal Pressure (CIAP) and Continuous Abdominal Perfusion Pressure (CAPP) Monitoring for Acute Kidney Injury (AKI) Prediuction in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
- ClinicalTrials.gov ID
- NCT07085286
- Acronym / sponsor ID
- PRESERVE-CABG / MUL_PRESERVE-CABG_001
- Conditions
- AKI - Acute Kidney Injury, CABG
- Keywords
- abdominal pressure, IAP, abdominal perfusion pressure, mean perfusion pressure, renal perfusion pressure, prediction, AKI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn whether high abdominal pressure or low blood flow pressure to the kidneys is linked to kidney injury after heart surgery. The main questions it aims to answer are:
Does high abdominal pressure increase the risk of kidney injury after cardiac surgery?
Can low blood flow pressure to the kidneys help predict who may develop kidney problems?
Participants in this study are adults undergoing heart surgery, such as coronary artery bypass grafting (CABG) or valve surgery. Researchers will measure abdominal pressure and blood pressure continuously before and after surgery using medical devices that are already part of routine care. This study does not involve any changes to standard treatment.
Participants will:
Have their abdominal and blood pressures continuously monitored using existing devices
Have blood and urine tests to check kidney function
Be followed during their hospital stay and up to 30 days after surgery to assess outcomes like length of stay, readmission, and survival
This study takes place at two hospitals-one in Poland and one in the United States. Researchers hope the findings will help identify early warning signs of kidney injury and improve monitoring practices after heart surgery.
Detailed description
This is a prospective, observational pilot study designed to investigate the relationship between elevated intra-abdominal pressure (IAP), impaired perfusion pressures, and the development of acute kidney injury (AKI) in adult patients undergoing cardiac surgery. The study will focus on whether continuous intra-abdominal pressure (CIAP) monitoring can provide early warning signs for AKI and other postoperative complications.
Intra-abdominal pressure (IAP) refers to the steady-state pressure within the abdominal cavity. In healthy individuals, IAP typically ranges between 5 and 7 millimeters of mercury (mmHg), while values may rise to around 10 mmHg in critically ill patients. Sustained IAP values at or above 12 mmHg define intra-abdominal hypertension (IAH). More severe elevations above 20 mmHg can result in abdominal compartment syndrome (ACS), which is associated with new organ dysfunction or failure. IAH can negatively impact multiple organ systems, including the kidneys, lungs, cardiovascular system, gastrointestinal tract, liver, and brain, through both mechanical and biochemical mechanisms.
Traditional IAP monitoring methods rely on intermittent measurement via the urinary bladder using a Foley catheter and saline instillation, performed at end-expiration with the patient in the supine position. Although this method is widely accepted, it is labor-intensive, operator-dependent, and cannot provide real-time pressure trends. As a result, diagnosis and management of IAH may be delayed.
Advancements in monitoring technology now allow for continuous IAP measurement using devices such as the TraumaGuard catheter. This dual-balloon Foley catheter provides real-time data on both IAP and core body temperature. It connects to standard intensive care unit (ICU) bedside monitors and allows continuous data capture and analysis.
This study will use continuous measurements of IAP, mean arterial pressure (MAP), central venous pressure (CVP), and mean alveolar pressure (Palv) to calculate key perfusion pressures:
Abdominal perfusion pressure (APP) = MAP - IAP
Mean perfusion pressure (MPP) = MAP - CVP
Renal perfusion pressure (RPP):
- In patients not receiving mechanical ventilation: RPP = MAP - IAP - CVP
- In mechanically ventilated patients: RPP = MAP - IAP - CVP - Palv
Continuous monitoring will also allow for the calculation of area under the curve (AUC) and time above threshold (TAT), providing a dynamic view of the pressure-time burden and potentially offering earlier insight into evolving complications. These data will be analyzed to assess whether sustained periods of low APP, MPP, or RPP are associated with higher rates of AKI and other adverse outcomes.
Cardiac surgery patients are considered at high risk for IAH due to fluid shifts, systemic inflammation, positive pressure ventilation, and reduced abdominal wall compliance. This study will capture multiple IAH risk factors, including patient demographics (e.g., obesity, body mass index, age), surgical variables (e.g., cardiopulmonary bypass duration, transfusion volume), and clinical factors (e.g., presence of sepsis, acidosis, or coagulopathy).
All participants will receive standard-of-care monitoring, including urinary catheters and arterial lines. The TraumaGuard catheter will be used only for data collection purposes and will not influence clinical management. No deviation from routine practice is required, and the study is entirely observational in nature.
The primary outcome is the incidence of acute kidney injury (AKI), diagnosed using Kidney Disease: Improving Global Outcomes (KDIGO) criteria. AKI will be identified by changes in serum creatinine levels and reductions in urine output during the first seven postoperative days. Secondary outcomes include myocardial injury, intensive care unit (ICU) and hospital length of stay, 30-day mortality, and hospital readmission.
Perfusion pressures (MAP, APP, MPP, RPP) will be analyzed to determine the duration and depth of hypotension relative to specific thresholds. All data will be collected continuously from bedside monitors and synchronized using timestamps to ensure accuracy. The TraumaGuard data will be integrated with beat-to-beat electronic medical record data (e.g., CapsuleTech or equivalent systems).
A total of 45 adult patients undergoing elective cardiac surgery (CABG or valve surgery) will be enrolled at two academic centers. This sample size is based on previous feasibility data and is expected to generate at least 12 AKI events, sufficient to explore statistical associations, estimate variance, and refine methodology for a larger follow-up study.
Descriptive statistics will be used to summarize perfusion pressures, with group comparisons between patients who develop AKI and those who do not. Receiver operating characteristic (ROC) curve analysis will be conducted to identify thresholds of IAP, APP, MPP, and RPP that predict AKI and other complications. A Kaplan-Meier survival analysis will be used to compare outcomes based on the presence of IAH and low perfusion pressures.
Due to the limited sample size, multivariable regression analysis will not be performed in this pilot phase.
This study aims to determine whether continuous intra-abdominal pressure monitoring can serve as a clinically valuable, noninvasive method for early detection of hemodynamic deterioration and AKI after cardiac surgery. The results may inform the design of larger-scale studies and help evaluate the potential role of IAP monitoring as a new vital sign in critical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with postoperative AKI | – | Device: Continous IAP measurementAccording to KDIGO criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This two-center prospective observational study will enroll adult patients undergoing cardiac surgery (e.g., coronary artery bypass grafting, valve surgery, or assist device placement). Participants will receive a TraumaGuard urinary catheter, which functions both as a standard Foley catheter and as a device for continuous intra-abdominal pressure monitoring. Data will be collected during and after surgery. An initial cohort of 45 patients will be analyzed for feasibility and to inform the sample size for future enrollment.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Undergoing cardiac surgery (CABG, valve surgery, combined procedures, heart transplantation, or placement of assist device)
- Expected hospital stay of at least one night
- Preoperative serum creatinine measurement available
- At least one postoperative serum creatinine measurement available
Key exclusion criteria (8 listed)
- Age below 18 years
- Incarcerated individuals
- No requirement for urinary catheter placement
- Presence of a do-not-resuscitate (DNR) order
- Pregnant or lactating individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous IAP measurementContinuous IAP measurement via existing Foley bladder catheter - allowing continuous APP, MPP and RPP calculation | Device | Patients with postoperative AKI |
Primary outcome
Incidence of acute kidney injury (AKI) in participants with and without intra-abdominal hypertension (IAH)
Time frame: Postoperative Days 0 through 7
To determine whether the presence of intra-abdominal hypertension (IAP ≥ 12 mmHg) is associated with a higher incidence of AKI follow. Measure Type: Binary outcome. Unit of Measure: % of participants with AKI. Method of Assessment: AKI will be diagnosed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, based on changes in serum creatinine and urine output. IAH will be defined as intra-abdominal pressure (IAP) ≥ 12 mmHg, measured using continuous intra-abdominal pressure monitoring.
5 secondary outcomes
Association between abdominal perfusion pressure (APP) and incidence of acute kidney injury (AKI)
Time frame: Postoperative Days 0 through 7
Association between mean perfusion pressure (MPP) and incidence of acute kidney injury (AKI)
Time frame: Postoperative Days 0 through 7
Association between renal perfusion pressure (RPP) and incidence of acute kidney injury (AKI)
Time frame: Postoperative Days 0 through 7
Association between intra-abdominal hypertension (IAH) and postoperative myocardial injury
Time frame: Postoperative Days 0 through 7
Agreement between intra-abdominal pressure (IAP) measurements using the TraumaGuard device and standard intermittent bladder pressure measurements
Time frame: Up to 48 hours post-surgery (duration of Foley catheter placement in ICU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 37829983Dang 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.
- Background: PubMed 40244889Goeddel LA, Hernandez M, Koffman L, Murphy Z, Khanna AK, Robich M, Whitman G, Zhou X, Bandeen-Roche K, Muschelli J 3rd, Parikh CR, Lima JAC, Crainiceanu CM, Brown C 4th, Faraday N. Fine-Mapping the Association of Acute Kidney Injury With Mean Arterial and Central Venous Pressures During Coronary Artery Bypass Surgery. Anesth Analg. 2025 Jun 1;140(6):1439-1449. doi: 10.1213/ANE.0000000000007500. Epub 2025 Apr 17.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
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- Individual participant dataSharing planned: Undecided. Needs to be defined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI - Acute Kidney Injury and CABG, run by Medical University of Lublin.
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 5 inclusion and 8 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Manu L Malbrain, MD, PhD (0032476244779, manu.malbrain@umlub.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (AKI) in participants with and without intra-abdominal hypertension (IAH) (time frame: Postoperative Days 0 through 7). 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 NCT07085286, which also lists 48 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 25 Jul 2025.