Perfusion Related Evaluation of Systemic and Renal Vulnerability to Events in CABG
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Lublin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age below 18 years
Incarcerated individuals
No requirement for urinary catheter placement
Presence of a do-not-resuscitate (DNR) order
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Continous IAP measurement
DeviceContinuous IAP measurement via existing Foley bladder catheter - allowing continuous APP, MPP and RPP calculation
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Patients with postoperative AKI1 intervention
Trial outcomes
Primary outcomes
1
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 7Secondary outcomes
1
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 72
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 73
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 74
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 7Locations
Sponsors and contacts
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Medical University of Lublin
Lead sponsor
Wake Forest University Health Sciences
Collaborator
Source ClinicalTrials.gov
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