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The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oscillometric blood pressure monitoring | Experimental | Intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring. |
|
| Intraarterial blood pressure monitoring | Active Comparator | Intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oscillometric blood pressure monitoring | Other | In patients assigned to oscillometric blood pressure monitoring, clinicians will be blinded to intraarterial blood pressure monitoring and intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring at 2.5-minute intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted average MAP <65 mmHg | Time-weighted average MAP <65 mmHg [mmHg], calculated from the start of surgery until the end of surgery (continuous endpoint) | From the start of surgery until the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Area under a MAP <65 mmHg | Area under a MAP <65 mmHg [mmHg min] (continuous endpoint) | From the start of surgery until the end of surgery |
| Total duration of MAP <65 mmHg | Total duration of MAP <65 mmHg [min] (continuous endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a composite binary outcome defined as the occurrence of at least one of the following: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death | Incidence of a composite binary outcome defined as the occurrence of at least one of the following within the first 30 postoperative days: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death (binary endpoint) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alina Bergholz | Contact | 004940 7410 0 | a.bergholz@uke.de | |
| Bernd Saugel | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| Intraarterial blood pressure monitoring | Other | In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine. |
|
| From the start of surgery until the end of surgery |
| Number of discrete hypotensive episodes | Number of discrete hypotensive episodes, defined as MAP <65 mmHg sustained for >1 min (count endpoint) | From the start of surgery until the end of surgery |
| Area above a MAP >100 mmHg | Area above a MAP >100 mmHg [mmHg min] (continuous endpoint) | From the start of surgery until the end of surgery |
| Time-weighted average MAP >100 mmHg | Time-weighted average MAP >100 mmHg [mmHg], calculated from randomization until the end of surgery (continuous endpoint) | From the start of surgery until the end of surgery |
| Average norepinephrine infusion rate | Average norepinephrine infusion rate [μg kg-1 min-1] (continuous endpoint) | From the start of surgery until the end of surgery |
| Total volume of administered crystalloids | Total volume of administered crystalloids [ml] (continuous endpoint) | From the start of surgery until the end of surgery |
| Within the first 30 postoperative days |
| Incidence of need for renal replacement therapy | Incidence of need for renal replacement therapy within the first 30 postoperative days (binary endpoint) | Within the first 30 postoperative days |
| Incidence of myocardial infarction | Incidence of myocardial infarction within the first 30 postoperative days (binary endpoint) | Within the first 30 postoperative days |
| Incidence of non-fatal cardiac arrest | Incidence of non-fatal cardiac arrest within the first 30 postoperative days (binary endpoint) | Within the first 30 postoperative days |
| Incidence of death | Incidence of death within the first 30 postoperative days (binary endpoint) | Within the first 30 postoperative days |
| Incidence of postoperative acute kidney injury | Incidence of postoperative acute kidney injury within the first 7 postoperative days (binary endpoint) | Within the first 7 postoperative days |