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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urethal perfusion index monitoring | Device | The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France) |
|
| Measure | Description | Time Frame |
|---|---|---|
| average intraoperative urethral perfusion index | Start of surgery until end of surgery |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernd Saugel, MD | Contact | +49741052415 | b.saugel@uke.de | |
| Moritz Flick, MD | Contact | +49741052415 | m.flick@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Bernd Saugel, MD | University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Not yet recruiting | Hamburg | Germany |
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| 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 |
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Germany |