In older patients having surgery, postoperative delirium (an acute disturbance in awareness, attention, or cognition) is common and associated with short-term and long-term morbidity and mortality. The pathophysiology of postoperative delirium is multifactorial - but presumably includes inadequate brain perfusion during surgery caused by low intraoperative blood pressure. Therefore, the investigators aim to determine in a multicenter randomized-controlled trial if targeted intraoperative blood pressure management reduces postoperative delirium. The investigators will test the primary hypothesis that maintaining intraoperative mean arterial pressure at 85 mmHg or higher - compared to at 65 mmHg or higher (routine care) - reduces the incidence of postoperative delirium within the first 3 postoperative days in older patients with arterial hypertension having non-cardiac surgery. The investigators will also assess the duration of postoperative delirium, postoperative complications, and the patients' quality of life. The results of this trial will have a direct impact on guidelines and will help improve medical care for patients and the patients' health. Effective strategies to prevent postoperative delirium are missing. The hypothesis that targeted intraoperative blood pressure management can help reduce postoperative delirium is supported by previous observational studies and interventional trials. This trial is supposed to confirm the causal relationship between intraoperative blood pressure and postoperative delirium and to demonstrate the effectiveness of the therapeutic approach.
1) be able to provide informed consent, AND
2) be ≥65 years old, AND
3) be scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥120 minutes, AND
4) have chronic arterial hypertension requiring antihypertensive medication OR have a systolic arterial pressure ≥140 mmHg or diastolic arterial pressure ≥90 mmHg on a measurement performed within the previous year, AND
solid organ transplant surgery
intracranial surgery
surgery in sitting position
sepsis
Parallel
MAP at 85 mmHg or higher (intervention group)
Other interventionIn patients assigned to the intervention group, clinicians will be instructed to maintain MAP at 85 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.
MAP at 65 mmHg or higher (control group)
Other interventionIn patients assigned to the control group, clinicians will be instructed to maintain MAP at 65 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.
Delirium within the first 3 postoperative days (binary outcome)
Delirium will be assessed on the day of surgery after transfer from the post-anesthesia care unit to the general ward or intensive care unit and twice daily on postoperative days 1, 2, and 3. The 3-Minute Diagnostic Confusion Assessment Method will be used for patients on general wards and the Confusion Assessment Method for the Intensive Care Unit for patients in intensive care units.
Days patients have delirium within the first 3 postoperative days (count outcome)
Delirium within the first 7 postoperative days (binary outcome)
Delirium will be based on systematic delirium assessments through postoperative day 3 and routine clinical screening from postoperative days 4 to 7.
Acute kidney injury within the first 7 postoperative days (binary outcome)
Acute kidney injury will be defined as an increase in serum creatinine of ≥50% from baseline or need for renal replacement therapy.
Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome)
Acute myocardial injury (Fourth Universal Definition 2018) will be defined as an increase in high-sensitivity troponin according to the definition of "myocardial injury and infarction associated with non-cardiac procedures" set forth in the Fourth Universal Definition of Myocardial Infarction (2018).
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Universitätsklinikum Hamburg-Eppendorf
Lead sponsor
Germany's Federal Ministry of Research, Technology and Space (BMFTR)
Collaborator