An observational study in AKI - Acute Kidney Injury and CABG, sponsored by Medical University of Lublin. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Medical University of Lublin · Observational
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.
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):
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 45 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Medical University of Lublin is the lead sponsor of 62 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
According to KDIGO criteria
Device: Continous IAP measurement
Continuous IAP measurement via existing Foley bladder catheter - allowing continuous APP, MPP and RPP calculation
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.
Time frame: Postoperative Days 0 through 7
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 48 hours post-surgery (duration of Foley catheter placement in ICU)
No study locations are listed for this record.
Plan to share: Undecided — Needs to be defined
Start is estimated for Jan 2026; primary completion for Jul 2026, 6 months later.
Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 6 months is below that.
Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Medical University of Lublin