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

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Urethral Perfusion Index; Microcirculation; Tissue Perfusion

Treatments: Device: urethal perfusion index monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06799832

2024-101408-BO-ff

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

116 participants in 2 patient groups

Routine hemodynamic management

No Intervention group

Description:

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 group

Description:

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

Treatment:

Device: urethal perfusion index monitoring