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

Not Applicable

Recruiting

• Conditions: Urethral Perfusion Index; Tissue Perfusion; Microcirculation

• Registration Number: NCT06799832
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-21
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
average intraoperative urethral perfusion index	Start of surgery until end of surgery

Secondary Outcome Measures

Name	Time	Method
the lowest intraoperative 5-minute moving average urethral perfusion index	Start of surgery until end of surgery
the absolute lowest intraoperative 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 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
the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index	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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany