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

NCT07085286 | Not Yet Recruiting FDA Device

• 1 other identifier: MUL_PRESERVE-CABG_001
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

AKI - Acute Kidney Injury; CABG

Keywords

abdominal pressure; IAP; abdominal perfusion pressure; mean perfusion pressure; renal perfusion pressure; prediction; AKI

Outcome Measures

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.

  Postoperative Days 0 through 7

Secondary Outcomes (5)

• Association between abdominal perfusion pressure (APP) and incidence of acute kidney injury (AKI)

  Postoperative Days 0 through 7

• Association between mean perfusion pressure (MPP) and incidence of acute kidney injury (AKI)

  Postoperative Days 0 through 7

• Association between renal perfusion pressure (RPP) and incidence of acute kidney injury (AKI)

  Postoperative Days 0 through 7

• Association between intra-abdominal hypertension (IAH) and postoperative myocardial injury

  Postoperative Days 0 through 7

• Agreement between intra-abdominal pressure (IAP) measurements using the TraumaGuard device and standard intermittent bladder pressure measurements

  Up to 48 hours post-surgery (duration of Foley catheter placement in ICU)

Study Arms (1)

Patients with postoperative AKI

According to KDIGO criteria

Device: Continous IAP measurement

Interventions

Continous IAP measurement DEVICE

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

Patients with postoperative AKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead
• Wake Forest University Health Sciences: collaborator

Related Publications (48)

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MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Manu L Malbrain, MD, PhD

CONTACT

0032476244779; manu.malbrain@umlub.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Critical Care Research, First Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07