Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial (UPRIGHT)

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.

Study Overview

• Status: Recruiting
• Conditions: Tissue Perfusion; Microcirculation; Urethral Perfusion Index
• Intervention / Treatment: Device: urethal perfusion index monitoring

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernd Saugel, MD; Phone Number: +49741052415; Email: b.saugel@uke.de
• Study Contact Backup: Name: Moritz Flick, MD; Phone Number: +49741052415; Email: m.flick@uke.de

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
  • Hamburg, Germany
    • Not yet recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Bernd Saugel, MD; Phone Number: +49 (0) 40 7410 - 52415; Email: b.saugel@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine hemodynamic management; In patients assigned to routine hemodynamic management, hemodynamic management will be performed according to routine care. The urethral perfusion index measurements will not be visible.
Experimental: Urethral perfusion index guided hemodynamic monitoring; In patients assigned to urethral perfusion index-guided hemodynamic monitoring, clinicians will be asked to maintaining the intraoperative urethral perfusion index above the postinduction baseline urethral perfusion index during surgery. Interventions to maintain intraoperative urethral perfusion index will be at the clinicians' discretion. All other medical procedures will be performed according to routine care. Clinical judgement will always prevail. Additionally, we will always strive to maintain macrocirculatory variables within predefined safety ranges: Mean arterial pressure: 60 mmHg - 120 mmHg Heart rate: 30 bpm - 120 bpm Cardiac index: at least 2.2 L/min/m2	Device: urethal perfusion index monitoring; The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
average intraoperative urethral perfusion index	Start of surgery until end of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
the absolute lowest intraoperative urethral perfusion index	Start of surgery until end of surgery
the lowest intraoperative 5-minute moving average urethral perfusion index	Start of surgery until end of surgery
the intraoperative area under the baseline urethral perfusion index	Start of surgery until end of surgery
the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index	Start of surgery until end of surgery
the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index	Start of surgery until end of surgery
intraoperative area under a urethral perfusion index value 30% below baseline	Start of surgery until end of surgery
cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline	Start of surgery until end of surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Bernd Saugel, MD, University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: microcirculation; tissue perfusion; urethral perfusion index
• Other Study ID Numbers: 2024-101408-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No