An interventional study of MAP at 85 mmHg or higher (intervention group) and MAP at 65 mmHg or higher (control group) in Postoperative Delirium (POD) and Intraoperative Hypotension, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Prevention
Among 29 studies in Emergence Delirium with a site in Germany — 7 open to participants now, 8 under way, none of them phase 3. Emergence Delirium · Germany.
Among the 29 studies in Emergence Delirium with a site in Germany, this one is one of 2 that started in 2026, is one of 9 with no phase, and was the 29th registered.
752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →7 of the 29 studies in Emergence Delirium with a site in Germany are open now. Recruiting first, the newest first:
Charite University, Berlin, Germany · Sites in Germany
Ages 18+
Hannover Medical School · Sites in Germany
Ages 18+
Technical University of Munich · Sites in Germany
Ages 65+
Heart and Brain Research Group, Germany · Sites in Germany
Ages 18+
Charite University, Berlin, Germany · Sites in Germany
Ages 70+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
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29 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 3,432 is above the median of 120 across 466 interventional studies indexed under Emergence Delirium.
Median enrollment 172 across the 9 interventional studies, 300 across the 19 observational. Of the 19 that completed or were terminated, 0 (0%) have results posted.
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None of the 29 has an industry lead sponsor. The 9 most frequent:
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Universitätsklinikum Hamburg-Eppendorf has 7 studies filed under Emergence Delirium — fewer than ten, so there is no comparison to draw.
1 of the studies in Emergence Delirium with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07568093Hannover Medical SchoolPARO-agitation-study | 2026-12 |
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Among the 29 studies in Emergence Delirium with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for trial inclusion, patients must:
Exclusion Criteria:
Patients that meet one or more of the following exclusion criteria cannot participate in the trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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.
Time frame: within the first 3 postoperative days
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)
Delirium will be based on systematic delirium assessments through postoperative day 3 and routine clinical screening from postoperative days 4 to 7.
Time frame: 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.
Time frame: 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).
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: postoperative day 180
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Oct 2029, 38 months after the start.
Of 186 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 38 months is above that.
Counting every sponsor, half of 186 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Universitätsklinikum Hamburg-Eppendorf →