Clinical trial NCT06799832: Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
Official title: Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urethral Perfusion Index
Tissue Perfusion
Microcirculation
Keywords: urethral perfusion index
tissue perfusion
microcirculation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 116
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.


Eligibility criteria: Inclusion Criteria:

* at least 45 years old
* scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes)
* indication for an arterial catheter
* indication for an urinary catheter

Exclusion Criteria:

* Pregnancy
* Planned surgery: nephrectomy, liver or kidney transplantation surgery
* Patients who previously had surgery on the urethra or bladder
* Patients without clinical indication for continuous blood pressure monitoring with an intraarterial catheter

Primary outcomes:
measure: average intraoperative urethral perfusion index
timeFrame: Start of surgery until end of surgery
Secondary outcomes:
measure: the absolute lowest intraoperative urethral perfusion index
timeFrame: Start of surgery until end of surgery
measure: the lowest intraoperative 5-minute moving average urethral perfusion index
timeFrame: Start of surgery until end of surgery
measure: the intraoperative area under the baseline urethral perfusion index
timeFrame: Start of surgery until end of surgery
measure: the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index
timeFrame: Start of surgery until end of surgery
measure: the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index
timeFrame: Start of surgery until end of surgery
measure: intraoperative area under a urethral perfusion index value 30% below baseline
timeFrame: Start of surgery until end of surgery
measure: cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline
timeFrame: Start of surgery until end of surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA
name: Bernd Saugel, MD
role: PRINCIPAL_INVESTIGATOR
References: