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The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | The intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement. To achieve the blood pressure target, fluid or vasoactive substances will be used. |
|
| Control group | Active Comparator | Study patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24 hour blood pressure measurement, fluids, vasopressors | Procedure | Targeting individual blood blood pressure values during surgical procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint: Incidence of POCD or delirium | POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test. | 3rd-7th postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney function | Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation) | 24, 48 and 72 hrs after surgery |
| cardiac ischemia | high-sensitive troponin T measurements are performed prior and 6 hours after surgery |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39050403 | Derived | Nicklas JY, Bergholz A, Dake F, Pham HHD, Rabe MC, Schlichting H, Skrovanek S, Flick M, Kouz K, Fischer M, Olotu C, Izbicki JR, Mann O, Fisch M, Schmalfeldt B, Frosch KH, Renne T, Krause L, Zollner C, Saugel B. Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial. BJA Open. 2024 Jul 1;11:100294. doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| D014662 | Vasoconstrictor Agents |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
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| Standard of Care | Procedure | Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf |
|
| 6 hours after surgery |
| length of hospital stay | 30 days |
| 30-day mortality | 30 days |
| 30-day morbidity | European perioperative outcome definitions | 30 days |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |