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| Name | Class |
|---|---|
| RWTH Aachen University | OTHER |
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The investigators propose a pilot trial to (1) proof the concept that defining the intraoperative mean arterial pressure (MAP) intervention threshold based on the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring) results in clinically relevant (mean nighttime MAP ± 10 mmHg) different target values compared with using an absolute population-derived MAP intervention threshold of 65 mmHg (primary endpoint); (2) investigate if a personalized perioperative blood pressure management is feasibly in multi-center studies, especially if the target values can be sufficiently achieved (secondary endpoint); (3) study the impact of personalized perioperative blood pressure management on the incidence of myocardial injury after non-cardiac surgery (MINS) (exploratory endpoint); (4) study the impact of personalized perioperative blood pressure management on the incidence of acute kidney injury within the first three postoperative days according to the KDIGO (Kidney Disease: Improving Global Outcomes) definition without oliguric criteria (exploratory endpoint).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized management group | Other | Intraoperative MAP will be maintained at least at the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring). If the mean nighttime MAP is below 65 mmHg, intraoperative MAP will be maintained at least at 65 mmHg. |
|
| Control group | No Intervention | Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients in the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized management | Other | Intraoperative MAP will be maintained at least at the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring). If the mean nighttime MAP is below 65 mmHg, intraoperative MAP will be maintained at least at 65 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| Individualized MAP target value | Difference between intraoperative target MAP (defined as the mean nighttime MAP assessed using preoperative automated blood pressure monitoring) and 65 mmHg; we consider a difference > ± 10 mmHg as clinically meaningful. | 1 day before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with calculated MAP target | - proportion of patients in whom preoperative automated blood pressure monitoring + calculation of target MAP is possible | day of surgery |
| Duration and severity of MAP below MAP target |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of myocardial injury after non-cardiac surgery | Incidence of myocardial injury after non-cardiac surgery assessed through measurement of baseline high-sensitivity troponin T (before surgery) and high-sensitivity troponin T on postoperative days 1,2, and 3. | baseline, postoperative days 1, 2 and 3 |
| Incidence of acute kidney injury |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Saugel, Prof. Dr. | Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany | Principal Investigator |
| Karim Kouz, Dr. | Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital RWTH Aachen | Aachen | 52074 | Germany | |||
| Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27792044 | Background | Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432. | |
| 30916004 |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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In control group patients, the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. Participants and outcomes assessors are blinded to group allocation.
- time weighted average MAP below individual MAP target
| day of surgery |
Incidence of acute kidney injury within the first three postoperative days according to the KDIGO definition without oliguric criteria assessed through measurement of baseline creatinine (before surgery) and creatinine after surgery on postoperative days 1, 2, and 3. |
| baseline, postoperative day 1, 2 and 3 |
| Hamburg |
| 20246 |
| Germany |
| Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27. |