Perioperative Personalized Blood Pressure Management
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
not provided
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Personalized management group 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. |
Other: Personalized management
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.
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No Intervention: Control group 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. |
Outcome Measures
Primary Outcome Measures
- Individualized MAP target value [1 day before surgery]
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.
Secondary Outcome Measures
- Proportion of patients with calculated MAP target [day of surgery]
- proportion of patients in whom preoperative automated blood pressure monitoring + calculation of target MAP is possible
- Duration and severity of MAP below MAP target [day of surgery]
- time weighted average MAP below individual MAP target
Other Outcome Measures
- Incidence of myocardial injury after non-cardiac surgery [baseline, postoperative days 1, 2 and 3]
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.
- Incidence of acute kidney injury [baseline, postoperative day 1, 2 and 3]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 45
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American Society of Anesthesiologists physical status class (ASA) II-IV
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scheduled for elective major surgery under general anesthesia
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surgery expected to last ≥ 120 minutes
Exclusion Criteria:
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emergency surgery
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patients having liver or kidney transplantation
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laparoscopic surgery
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pregnancy
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status of post transplantation of kidney, liver, heart, or lung
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sepsis (according to current Sepsis-3 definition)
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impossibility of preoperative automated blood pressure monitoring
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MAP differences between the right and the left arm of more than 20 mmHg surgery that requires controlled hypotension
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Hospital RWTH Aachen | Aachen | Germany | 52074 | |
2 | Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- RWTH Aachen University
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 2021-10462-BO-bet