Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery

NCT07713121 | Not Yet Recruiting

• 1 other identifier: 2026-101764-BO-ff
• Study Type: interventional
• Target: 3,432
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium (POD); Intraoperative Hypotension

Keywords

anesthesia; cardiovascular dynamics; hemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  within the first 3 postoperative days

Secondary Outcomes (13)

• Days patients have delirium within the first 3 postoperative days (count outcome)

  within the first 3 postoperative days

• Delirium within the first 7 postoperative days (binary outcome)

  within the first 7 postoperative days

• Acute kidney injury within the first 7 postoperative days (binary outcome)

  within the first 7 postoperative days

• Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome)

  within the first 7 postoperative days

• Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome)

  within the first 7 postoperative days

Study Arms (2)

MAP at 85 mmHg or higher (intervention group)

EXPERIMENTAL

In 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 end at the end of surgery.

Other: MAP at 85 mmHg or higher (intervention group)

MAP at 65 mmHg or higher (control group)

OTHER

In 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 end at the end of surgery.

Other: MAP at 65 mmHg or higher (control group)

Interventions

MAP at 85 mmHg or higher (intervention group) OTHER

In 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 85 mmHg or higher (intervention group)

MAP at 65 mmHg or higher (control group) OTHER

In 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.

MAP at 65 mmHg or higher (control group)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \) be able to provide informed consent, AND
• \) be ≥65 years old, AND
• \) be scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥120 minutes, AND
• \) 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
• \) 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)

You may not qualify if:

• solid organ transplant surgery
• intracranial surgery
• surgery in sitting position
• sepsis
• surgery in the previous 30 days
• previous participation in ASPIRE-85

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• BMBF (Bundes Ministerium für Bildung und Forschung): collaborator

Study Sites (1)

• Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg

Hamburg, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Karim Kouz, MD

CONTACT

+4940741052415; k.kouz@uke.de

Bernd Saugel, MD

CONTACT

+4940741052415; b.saugel@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients, outcome assessors, outcome adjudicators, and data analysts will be blinded to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DE (1)