Postoperative Delirium (POD)ASPIRE-85NCT07713121
Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery
A study testing MAP at 85 mmHg or higher (intervention group) in people with Postoperative Delirium (POD) and Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Intraoperative Hypotension
- What is being tested?
- MAP at 85 mmHg or higher (intervention group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,432 participants
- Where
- 1 siteGermany
- Study dates
- 21 Aug 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
• Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg
Hamburg
Karim Kouz, MD, +4940741052415, k.kouz@uke.de
About this study
Official title: Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery: the Multicenter Randomized ASPIRE-85 Trial
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.
- Being tested
- MAP at 85 mmHg or higher (intervention group), MAP at 65 mmHg or higher (control group)
- Keywords
- anesthesia, cardiovascular dynamics, hemodynamic monitoring
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MAP at 65 mmHg or higher (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 3 postoperative days
Secondary outcomes (13)
Days patients have delirium within the first 3 postoperative days (count outcome)
Measured: within the first 3 postoperative days
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.
Measured: within the first 7 postoperative days
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.
Measured: within the first 7 postoperative days
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).
Measured: within the first 7 postoperative days
Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome)
Acute myocardial injury (latest definition at time of analysis) will be defined according to the latest applicable universal definition available at the time of the final analysis; this definition will be prespecified in the statistical analysis plan before database lock and unblinding.
Measured: within the first 7 postoperative days
Stroke within the first 7 postoperative days (binary outcome)
Stroke will be defined as any documented diagnosis of stroke in the medical record.
Measured: within the first 7 postoperative
Days alive and out of hospital within the first 90 postoperative days (count outcome)
Days alive and out of hospital within the first 90 postoperative days will be defined as the number of days patients are alive and not hospitalized during the first 90 days after surgery. Patients who die within 90 days will be assigned 0 days alive and out of hospital.
Measured: within the first 90 postoperative days
Time until all-cause death within the first 90 postoperative days (time-to-event outcome)
Time to all-cause death within 90 postoperative days will be defined as the time from surgery to death from any cause. Patients alive at 90 days will be censored at 90 days.
Measured: within the first 90 postoperative days
Time until discharge from hospital within the first 90 postoperative days (time-to-event outcome)
Time to hospital discharge within 90 postoperative days will be defined as the time from surgery to hospital discharge; patients not discharged will be censored at death, trial withdrawal, or 90 days, whichever occurs first.
Measured: within the first 90 postoperative days
Long-term cognitive function at postoperative day 180 (continuous outcome)
Long-term cognitive function will be assessed before surgery and at postoperative day 180 using the 5-minute Montreal Cognitive Assessment (minimal score: 0 points, maximal score: 15 points; with higher scores indicating better cognitive function).
Measured: postoperative day 180
Quality of recovery at postoperative day 2 (continuous outcome)
Quality of recovery will be assessed before surgery and 48 hours after surgery using the Quality of Recovery-15 questionnaire (minimal score: 0 points, maximal score: 150 points; with higher scores indicating better quality of recovery).
Measured: postoperative day 2
Quality of life at postoperative day 180 (visual analog scale; continuous outcome)
Quality of life will be assessed before surgery and at postoperative day 180 using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire (visual analog scale; minimal score: 0, maximal score: 100; with higher scores indicating better quality of life).
Measured: postoperative day 180
Quality of life at postoperative day 180 (index value; continuous outcome)
Quality of life will be assessed before surgery and at postoperative day 180 using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire (index value using the German population value set; maximal score: 1.000; with higher scores indicating better quality of life).
Measured: postoperative day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start21 Aug 2026
- Primary completionOct 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Germany's Federal Ministry of Research, Technology and Space (BMFTR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713121
- Sponsor's protocol ID
- 2026-101764-BO-ff
- Acronym
- ASPIRE-85
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable written request, pseudonymized patient data may be shared with researchers who provide a methodologically sound proposal. Data will be shared only for analyses consistent with the approved proposal and after approval by the trial steering committee and execution of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery: the Multicenter Randomized ASPIRE-85 Trial
- ClinicalTrials.gov ID
- NCT07713121
- Acronym / sponsor ID
- ASPIRE-85 / 2026-101764-BO-ff
- Keywords
- anesthesia, cardiovascular dynamics, hemodynamic monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,432 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Germany's Federal Ministry of Research, Technology and Space (BMFTR)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAP at 85 mmHg or higher (intervention group) | Experimental | Other: MAP at 85 mmHg or higher (intervention group)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. |
| MAP at 65 mmHg or higher (control group) | Other | Other: MAP at 65 mmHg or higher (control group)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAP at 85 mmHg or higher (intervention group)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. | Other | MAP at 85 mmHg or higher (intervention group) |
| MAP at 65 mmHg or higher (control group)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. | Other | MAP at 65 mmHg or higher (control group) |
Primary outcome
Delirium within the first 3 postoperative days (binary outcome)
Time frame: within the first 3 postoperative days
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.
13 secondary outcomes
Days patients have delirium within the first 3 postoperative days (count outcome)
Time frame: within the first 3 postoperative days
Delirium within the first 7 postoperative days (binary outcome)
Time frame: within the first 7 postoperative days
Acute kidney injury within the first 7 postoperative days (binary outcome)
Time frame: within the first 7 postoperative days
Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome)
Time frame: within the first 7 postoperative days
Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome)
Time frame: within the first 7 postoperative days
Stroke within the first 7 postoperative days (binary outcome)
Time frame: within the first 7 postoperative
Days alive and out of hospital within the first 90 postoperative days (count outcome)
Time frame: within the first 90 postoperative days
Time until all-cause death within the first 90 postoperative days (time-to-event outcome)
Time frame: within the first 90 postoperative days
Time until discharge from hospital within the first 90 postoperative days (time-to-event outcome)
Time frame: within the first 90 postoperative days
Long-term cognitive function at postoperative day 180 (continuous outcome)
Time frame: postoperative day 180
Quality of recovery at postoperative day 2 (continuous outcome)
Time frame: postoperative day 2
Quality of life at postoperative day 180 (visual analog scale; continuous outcome)
Time frame: postoperative day 180
Quality of life at postoperative day 180 (index value; continuous outcome)
Time frame: postoperative day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable written request, pseudonymized patient data may be shared with researchers who provide a methodologically sound proposal. Data will be shared only for analyses consistent with the approved proposal and after approval by the trial steering committee and execution of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP at 85 mmHg or higher (intervention group) in people with Postoperative Delirium (POD) and Intraoperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Kouz, MD (+4940741052415, k.kouz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium within the first 3 postoperative days (binary outcome) (time frame: within the first 3 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.