Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery
Recruiting · NCT07713121 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- To be eligible for trial inclusion, patients must:
- 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
- 5\) be at high risk for postoperative delirium because: American Society of Anesthesiologists physical status class III or IV OR Charlson Comorbidity Index ≥3 points (please see Appendix 1) OR frailty (documented in medical records or clinical diagnosis)
Exclusion criteria
- Patients that meet one or more of the following exclusion criteria cannot participate in the trial:
- solid organ transplant surgery
- intracranial surgery
- surgery in sitting position
- sepsis
- surgery in the previous 30 days
- previous participation in ASPIRE-85
Where it is running
1 location listed.
- • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg - Hamburg, Germany