An observational study in Postoperative Delirium, Postoperative Stroke and Postoperative Cognitive Dysfunction, sponsored by University Hospital, Basel, Switzerland. Recruiting at 4 sites in 2 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University Hospital, Basel, Switzerland · Observational
Among 11 studies in Emergence Delirium with a site in Switzerland — 3 open to participants now, 3 under way, none of them phase 3. Emergence Delirium · Switzerland.
Among the 11 studies in Emergence Delirium with a site in Switzerland, this one is the only one that started in 2023, is one of 8 observational ones, and was the 9th registered.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →3 of the 11 studies in Emergence Delirium with a site in Switzerland are open now. Recruiting first, the newest first:
Julian Rössler · Sites in Switzerland
Ages 65+
University Hospital, Basel, Switzerland · Sites in Switzerland
Ages 60+
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 143 Emergence Delirium studies recruiting now, 78 (55%) set no upper age limit and 45 (31%) stop at 75 or younger; 35 take children under 18; 25 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 162 across 279 observational studies indexed under Emergence Delirium.
Median enrollment 200 across the 3 interventional studies, 473 across the 8 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 4 most frequent:
University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
University Hospital, Basel, Switzerland has 8 studies filed under Emergence Delirium — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Emergence Delirium with a site in Switzerland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.
Adverse neurological events include perioperative neurocognitive disorders and stroke and remain one of the major risks after cardiac surgery. A lack of a comprehensive knowledge of their causes and neuroprotective strategies has hindered the development of strategies to effectively reduce these complications. Against this background, this research project will take three approaches. First, non-invasive, personalised cerebral autoregulation-oriented blood pressure monitoring aims to reduce complications by uncovering blood pressure targets tailored to individual characteristics. In parallel, establishing biological associations between adverse neurological outcomes, brain injury biomarkers and genetic studies are complementary strategies that make a move to a proactive patient-tailored paradigm, ultimately understanding the mechanisms and improving patient outcomes, patient safety and quality of life.
Therefore, this international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of MAP outside of an individual's CA limits using NIRS and TCD are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults, defined by the duration and magnitude spent outside of an individual's CA limits based on NIRS and/or TCD, have an increased incidence of postoperative delirium (POD), stroke or cognitive decline. Biological associations between adverse neurological outcomes, the role of brain injury serum biomarkers will be explored. Genetic studies will be conducted on participants who give written informed consent for these further investigations.
The target population consists of in-hospital patients undergoing cardiac surgery at three centres in two European countries. Patients will be screened for eligibility. Therefore, consecutive ongoing recruitment of patients fulfilling the in- and exclusion criteria will take place during daily clinical practice at the participating hospitals.
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.
Exclusion Criteria:
Participants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.
Preoperatively, patients will be assessed with Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale (GDS), Clinical Frailty Scale, 3-minute Diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM, incl. severity score), modified National Institutes of Health Stroke Scale (mNIHSS), and hand grip strength measurement (using a hand dynamometer) to establish a baseline measurement of the physical, cognitive and mental status.
Intraoperatively, NIRS data will be collected and recorded in real-time.
Intraoperatively, TCD data will be collected and recorded in real-time.
Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.
Postoperatively, NIRS monitoring will be continued in the ICU after the surgery until (i) endotracheal extubation, or (ii) for the first 24 hours or (iii) until emergency re-operation, whichever occurs first.
Postoperatively patients will be evaluated for POD with 3D-CAM or CAM-ICU and for clinical stroke with mNIHSS. Postoperative neurocognitive disorders will be assessed using MoCA.
The serum biomarker panel will consist, at least, of four markers of neurological injury glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), total tau and ubiquitin-carboxy-terminal hydrolase-L1 (UCH-L1). Blood samples will be obtained preoperatively, after ICU admission, on postoperative day 1, 2, 6 (or hospital discharge, whichever occurs first) and between 6 and 12 weeks after surgery.
A blood sample for the genetic study will be obtained preoperatively.
Change in 3D-CAM to assess postoperative delirium (POD)
Change in 3D-CAM to assess POD. The 3D-CAM rates four diagnostic features, including acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. Delirium scored as 'present' (1) or 'absent' (0) based on question responses.
Time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
Change in Confusion Assessment Method for the ICU (CAM-ICU) to assess postoperative delirium (POD)
CAM-ICU is an adaptation of the CAM to be usable by clinicians to screen for delirium in the intensive care unit setting designed for intubated patients. The CAM-ICU utilizes the CAM diagnostic algorithm. There are four core features including acute onset or fluctuating course, inattention, disorganized thinking, and altered level of consciousness rated with 8 items. 3 of the 4 features must be present for CAM-ICU to be considered positive, according to the original CAM algorithm. Items are rated absent/present base on specific thresholds.
Time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
Change in modified National Institutes of Health Stroke Scale (mNIHSS)
Change in mNIHSS to assess postoperative clinical stroke
Time frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
Change in Montreal Cognitive Assessment (MoCA)
Change in MoCA to assess postoperative neurocognitive disorder
Time frame: Between 6 weeks and 12 weeks, and up to 12 months after surgery
Postoperative increase in serum creatinine
Postoperative increase in serum creatinine of ≥ 26.5 μmol/l (≥ 0.3 mg/dl) within 48 hours or ≥ 1.5 times of baseline to assess acute kidney injury
Time frame: Within 48 hours after surgery
De novo renal replacement therapy
De novo renal replacement therapy
Time frame: Within postoperative day 7 (or up to discharge)
Major morbidity
Major morbidity as defined by the Society of Thoracic Surgeons as having at least one of the following adverse outcomes: stroke, surgical re-exploration for any cardiac reason (bleeding, coronary graft occlusion, valve dysfunction, and others), renal failure, deep sternal wound infection/mediastinitis, and prolonged ventilation (\> 24 hours)
Time frame: Within postoperative day 7 (or up to discharge)
Intensive care unit (ICU) stay (in hours)
Number of hours in ICU
Time frame: From day of surgery until discharge from ICU (approx. 1 day)
Length of hospital stay (in days)
Number of days in hospital
Time frame: From day of surgery until discharge from hospital (approx. 7 days)
Perioperative mortality
Perioperative mortality, defined as any in-hospital or postdischarge death within 30 days after surgery, regardless of cause, or any death occurring during the hospitalisation, even after 30 days
Time frame: Within within 30 days after surgery
Change in brain injury biomarker panel
The serum biomarker panel consists of at least four markers of neurological injury: glial fibrillary acidic protein (GFAP), neurofilament light (NfL), total tau, and ubiquitin-carboxy-terminal hydrolase-L1 (UCH-L1).
Time frame: At preoperative screening; at day of surgery; at postoperative day 1, 2 and 6 (or hospital discharge, whichever occurs first); between 6 weeks and 12 weeks after surgery
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Ran from Jan 2023 to primary completion in May 2026, 39 months.
Of 181 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 39 months is above that.
Counting every sponsor, half of 181 studies reached it within 21 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland →