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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • urethal perfusion index monitoring

    Device

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

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Routine hemodynamic managementNo intervention 0 interventions
Group B: Urethral perfusion index guided hemodynamic monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

average intraoperative urethral perfusion index

Time frame
Start of surgery until end of surgery

Secondary outcomes

1

the absolute lowest intraoperative urethral perfusion index

Time frame
Start of surgery until end of surgery
2

the lowest intraoperative 5-minute moving average urethral perfusion index

Time frame
Start of surgery until end of surgery
3

the intraoperative area under the baseline urethral perfusion index

Time frame
Start of surgery until end of surgery
4

the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index

Time frame
Start of surgery until end of surgery

Other outcomes

Sponsors and contacts

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