An observational study in Postoperative Neurocognitive Dysfunction, Postoperative Neurocognitive Disorder and Cardiac Surgery, sponsored by Ziekenhuis Oost-Limburg. Completed at 1 site in Belgium. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Ziekenhuis Oost-Limburg · Observational
Among 46 studies in Fatigue with a site in Belgium — 9 open to participants now, 12 under way, 3 of them phase 3. Fatigue · Belgium.
Among the 46 studies in Fatigue with a site in Belgium, this one is the 7th largest by enrollment of the 13 observational ones that give a count, is one of 9 that started in 2025, is one of 13 observational ones, and was the 40th registered.
2,232 studies on the registry are indexed under Fatigue; 428 are open to participants now.
Browse Fatigue studies →9 of the 46 studies in Fatigue with a site in Belgium are open now. Recruiting first, the newest first:
University Hospital, Ghent · Sites in Belgium
Ages 18+
Université Catholique de Louvain · Sites in Belgium
Ages 18–40 · Men only · Healthy volunteers
Alkermes, Inc. · Sites in Belgium, United States, Australia and 7 more countries
Ages 18–70
Vrije Universiteit Brussel · Sites in Belgium
Ages 18–35 · Healthy volunteers
Pfizer · Sites in Belgium, United States, Australia and 18 more countries
Ages 18+
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 240 Fatigue studies recruiting now, 111 (46%) set no upper age limit and 99 (41%) stop at 75 or younger; 23 take children under 18; 73 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
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46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 5 · Phase 4 3
First in 2005; this study’s year is marked. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 89 is below the median of 99 across 406 observational studies indexed under Fatigue.
Median enrollment 55 across the 33 interventional studies, 89 across the 13 observational. Of the 28 that completed or were terminated, 0 (0%) have results posted.
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5 of 46 have an industry lead sponsor. The 10 most frequent:
Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 16 are open to participants now.
Ziekenhuis Oost-Limburg has 2 studies filed under Fatigue — fewer than ten, so there is no comparison to draw.
3 of the studies in Fatigue with a site in Belgium that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07355101Universiteit AntwerpenPersonalized Exercise Coaching to Improve Quality of Life in Pediatric IBD | 2027-04-01 |
| NCT07840872Vrije Universiteit BrusselExploring the Effect of the Hypershell Hip Exoskeleton on Fatiguing, Everyday Activities in Older Adults | 2027-06 |
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Among the 46 studies in Fatigue with a site in Belgium, from their registry updates:
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RATIONALE: Postoperative cognitive changes are common after cardiac surgery and can be categorised into three main types: postoperative delirium (POD), delayed neurocognitive recovery (DNCR) and postoperative neurocognitive disorder (PNCD). DNCR is diagnosed until postoperative day 30 and PNCD is diagnosed at least 30 days after the operation. Both conditions can be mild or major, and can affect the quality of life of these patients.
The incidence of PNCD in cardiac surgery is around 40%. Despite this high incidence, screening for PNCD is absent in current postoperative care since the diagnosis of PNCD is difficult and very time intensive. Furthermore, the underlying pathogenesis is incompletely understood.
The identification of a biomarker and/or validated short diagnostic instrument would be of paramount importance to easily identify patients at risk, or to diagnose patients with PNCD in order to identify therapeutical pathways for this disease.
OBJECTIVES: The main objective of this prospective clinical trial is to evaluate the performance of the short NPA and/or biochemical markers for the diagnosis of DNCR and PNCD in cardiac surgery patients aged 60 years or older.
STUDY DESIGN: Single-centre interventional observational study
STUDY INTERVENTIONS: Patients will undergo a neurophysiological assessment (NPA) pre-operatively and at two timepoints post-operatively, namely 6 (+/-1) days and 40 (+/- 10) days after surgery. During the stay at the intensive care unit, they will be screened daily for delirium, using the CAM-ICU and 3D-CAM.
To evaluate whether the development of DNCR or POD has an important effect on quality of recovery , the quality of recovery scale 15 (QOR-15), muscle strength (handgrip strength) and the Chalder fatigue score will be scored post-operative (postop day 1, 3 and 5). To evaluate whether PNCD has an effect on quality of live the EQ5D5L score will be measured at 40 (+/- 10) days after surgery, compared to preoperative values.
On several time points, blood samples will be drawn to measure markers of neuroinflammation. The time points will be preoperatively, at the moment of arrival on ICU, postoperative day 1, 2 and 3, if still on ICU. Two repeat blood sample will be taken at the moment of NPA performed after 6 (+/- 1) days and 40 (+/- 10) days after surgery, if the patient is willing (not obligatory).
STUDY POPULATION:
Patients aged 60 years or older who are scheduled for cardiac surgery.
Inclusion criteria:
Exclusion criteria:
MAIN STUDY ENDPOINTS:
Primary outcome PNCD defined as a decline of > 1 SD on > 2 tests in one or more cognitive domains or a decline of > 1 SD on total cognitive domain score.
Secondary outcomes Postoperative delirium - CAM-ICU will be evaluated twice daily (morning and evening) on every day when the patient is awake (not intubated) on the ICU. This is standard of care and is part of the routine clinical care in the hospital. Furthermore, once daily a 3D-CAM will be performed on day 1, 3 and 5.
Quality of recovery
Biochemical analysis
- Blood samples will be drawn for analysis before induction of anaesthesia (preoperatively), at the end of the operation (immediately postoperatively on arrival in ICU), on day 1, 2 and 3 postoperatively (if still at the ICU) and at the time of the postoperative follow-up visits with the NPA testing (day 6 (+/-1) and day 40 (+/-10) days post-surgery).
At each time point, markers of neuroinflammation and -degeneration will be determined.
Tertiary outcomes
Since, compared to younger patients undergoing major surgery, elderly patients are more prone to develop PNCD and are at greater risk of morbidity, we will therefore include patients aged 60 years or older scheduled for cardiac surgery.
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:
Observational study design - no intervention
Incidence of postoperative neurocognitive disorder (PNCD) after cardiac surgery using the NPA.
The neuropsychological assessment (NPA) consists of 17 subsets which can be divided into five cognitive domains: speed and attention, memory, language, executive and visuospatial functioning. The outcomes are 21 scores, namely the scores of the 17 subsets and 4 combined scores. These are reported in T-scores after correction for age and educational level by comparison with a norm group. PNCD is defined as a decline of \> 1 SD on \> 2 tests in one or more cognitive domains or a decline of \> 1 SD on total cognitive domain score.
Time frame: The NPA will be taken preoperatively and postoperatively on day 40 (+/- 10).
Delayed neurocognitive recovery (DNCR)
Neurocognitive disorder early after surgery (\< 30 days) will be assessed using the NPA (similar to the primary outcome).
Time frame: Day 6 (+/- 1) following surgery.
Postoperative delirium (CAM-ICU)
To assess postoperative delirium on the ICU the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) questionnaire will be done twice daily (morning and evening) every day when the patient is in the ICU. The CAM-ICU is a structured assessment tool. Based on the patient's responses and performance, it is determined whether delirium is present or not.
Time frame: Twice daily (morning and evening) day 1 - day 5 following surgery if the patient is still in the ICU.
Postoperative delirium (3D-CAM)
To assess postoperative delirium the 3 minute confusion assessment method (3D-CAM) questionnaire will be done on day 1, day 3 and day 5 postoperatively. The 3D-CAM consists of a structured interview and cognitive testing. Based on the patient's responses and performance, it is determined whether delirium is present or not.
Time frame: Postoperative day 1, day 3 and day 5.
Quality of recovery (QoR-15)
Quality of Recovery Score (QoR-15 score) is a patient-reported outcome measurement which will be used to assess the early postoperative health status of the patient after surgery and anaesthesia, i.e. the quality of recovery. The score is arbitrary and ranges from 0 to 150, the higher the score the better the quality of recovery.
Time frame: Preoperative, postoperative day 1, day 3 and day 5.
Postoperative muscle strength (HGS)
Postoperative muscle strength (upper extrimity) will be assessed by comparing the handgrip strength (HGS) of the dominant hand, measured on day 1, day 3, day 5, day 6 (+/- 1), and day 40 (+/- 10) following surgery as compared to the preoperative value.
Time frame: Preoperative, postoperative day 1, day 3, day 5, day 6 (+/- 1), and day 40 (+/- 10).
Postoperative fatigue (CFQ)
To assess general fatigue a fatigue questionnaire, the Chalder fatigue questionnaire (CFQ), will be taken on day 1, day 3, day 4, day 6 (+/- 1) and day 40 (+/- 10) postoperatively. The questionnaire consists of 11 items that assess both physical and mental aspects of fatigue. Respondents rate each item ranging from 0 to 3, the scores are then totaled to provide a measure of overall fatigue, a higher score meaning more severe fatigue.
Time frame: Preoperative, postoperative day 1, day 3, day 5, day 6 (+/- 1), and day 40 (+/- 10).
Health-related quality of life (EQ5D5L)
The EQ-5D-5L is used for measuring health-related quality of life. EQ-5D-5L provides a simple descriptive profile and a single index value for health status, both can be used to assess overall helaht. The descriptive profile consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, or not able. Respondents select the level that best describes their current health status. The EQ-5D-5L also includes a visual analog scale (VAS) where respondents rate their current health status on a scale from 0 to 100, with 0 being the worst imaginable health state and 100 being the best imaginable health state.
Time frame: Preoperative and postoperative day 40 (+/- 10).
Subjective sleep quality (PSQI)
To assess subjective sleep quality the Pittsburgh Sleep Quality Index (PSQI) will be used. The PSQI consists of 19 items that assess different components of sleep, including sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction due to poor sleep quality. Each item is rated on a scale from 0 to 3, with higher scores indicating worse sleep quality. The scores from all 19 items are summed to provide a total score ranging from 0 tot 21, with higher scores indicating poorer sleep quality. The questionnaire will be filled in 3 times: before surgery, day 6 (+/-1) and day 40 (+/- 10) after surgery.
Time frame: Preoperative, postoperative day 6 (+/- 1), and day 40 (+/- 10).
Sleeping EEG pattern
Electroencephalographic (EEG) readings will be conducted during the first postoperative night to asses sleep architecture.
Time frame: First postoperative night.
Markers of neuroinflammation and neurodegeneration
Blood samples will be drawn for analysis before induction of anaesthesia (preoperatively), at the end of surgery on arrival in ICU, on day 1, 2 and 3 postoperatively (if still in the ICU) and at the time of follow-up visits on day 6 (+/- 1) and day 40 (+/- 10) post-surgery. Markers of neuroinflammation and neurodegeneration (Phospho-Tau, NfL) will be determined.
Time frame: Before induction of anaesthesia, immediately postoperative (on arrival in ICU), day 1, day 2 and day 3 postoperative (if still in ICU), day 6 (+/- 1) and day 40 (+/- 10).
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2025 to primary completion in Oct 2026, 12 months.
Of 156 non-industry observational studies under Fatigue, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 61. This study's 12 months is below that.
Counting every sponsor, half of 166 studies reached it within 24 months; a quarter within 7 and three quarters within 42.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Oost-Limburg