Perfusion Related Evaluation of Systemic and Renal Vulnerability to Events in CABG

NCT ID: NCT07085286

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

Brief 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 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.

Conditions

AKI - Acute Kidney Injury; CABG

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with postoperative AKI

According to KDIGO criteria

Continous IAP measurement

Intervention Type: DEVICE

Continuous IAP measurement via existing Foley bladder catheter - allowing continuous APP, MPP and RPP calculation

Interventions

Continous IAP measurement

Continuous IAP measurement via existing Foley bladder catheter - allowing continuous APP, MPP and RPP calculation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

Medical University of Lublin

OTHER

Sponsor Role: lead

Responsible Party

Manu Malbrain

Professor Critical Care Research, First Department of Anaesthesiology and Intensive Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Manu L Malbrain, MD, PhD

Role: CONTACT

manu.malbrain@umlub.pl

0032476244779

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Other Identifiers

MUL_PRESERVE-CABG_001

Identifier Type: -

Identifier Source: org_study_id