Actively Recruiting
Urethral Perfusion Index-Guided Hemodynamic Management in Patients Undergoing Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-02-21
116
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether maintaining the urethral perfusion index at or above the baseline measured after anesthesia induction improves intraoperative tissue perfusion during major abdominal surgery. This single-center pilot trial compares routine hemodynamic management to urethral perfusion index-guided management, using a randomized and single-blinded design. The study also explores the relationship between urethral perfusion index and other heart and peripheral perfusion measurements as planned substudies. Participants undergoing elective major abdominal surgery lasting at least 120 minutes will be randomly assigned to either routine care, where urethral perfusion index is measured but hidden from clinicians, or to a group where clinicians aim to keep the urethral perfusion index above the postinduction baseline during surgery. The index is monitored using the IKORUS System device. Interventions to maintain the index are at the clinician's discretion, while also maintaining standard macrocirculatory safety parameters such as blood pressure, heart rate, and cardiac index. During the surgery, researchers will continuously monitor the urethral perfusion index and related cardiovascular variables. The main measurement is the average intraoperative urethral perfusion index from the start to the end of surgery. Secondary outcomes include the lowest values, time spent below baseline, and related perfusion metrics. This monitoring aims to assess tissue perfusion and microcirculation under different management strategies, with participation lasting through the surgical procedure.
CONDITIONS
Brief Title
Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 45 years old
- Scheduled for elective major abdominal surgery involving visceral organs, expected to last at least 120 minutes
- Clinical indication for an arterial catheter
- Clinical indication for a urinary catheter
You will not qualify if you...
- Pregnancy
- Planned surgery including nephrectomy, liver or kidney transplantation
- Previous surgery on the urethra or bladder
- No clinical indication for continuous blood pressure monitoring with an intraarterial catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of surgery (at least 120 minutes)
Participants undergo major abdominal surgery during which hemodynamic management is guided by urethral perfusion index monitoring or routine care. The surgery and monitoring last for the duration of the operation, typically at least 120 minutes.
1 visit (in-person) covering surgery and monitoring
Trial Site Locations
Total: 2 locations
1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Not Yet Recruiting
2
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
Research Team
B
Bernd Saugel, MD
M
Moritz Flick, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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