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

NCT06799832 | Recruiting

• 1 other identifier: 2024-101408-BO-ff
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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.

Conditions

Urethral Perfusion Index; Tissue Perfusion; Microcirculation

Keywords

urethral perfusion index; tissue perfusion; microcirculation

Outcome Measures

Primary Outcomes (1)

• average intraoperative urethral perfusion index

  Start of surgery until end of surgery

Secondary Outcomes (7)

• 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

Study Arms (2)

Routine hemodynamic management

NO INTERVENTION

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.

Urethral perfusion index guided hemodynamic monitoring

EXPERIMENTAL

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

Interventions

urethal perfusion index monitoring DEVICE

The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)

Urethral perfusion index guided hemodynamic monitoring

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (2)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

NOT YET RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Study Officials

• Bernd Saugel, MD

  University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernd Saugel, MD

CONTACT

+49741052415; b.saugel@uke.de

Moritz Flick, MD

CONTACT

+49741052415; m.flick@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: January 21, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)