Last reviewed · How we verify
NCT05765162: SBI
Safe Brain Initiative, Operationalizing Precision Anaesthesia
trial testing Patient reported ourcomes in Neurocognitive Disorders in 15,000 participants. Currently enrolling.
1 January 2025
Quick facts
| Lead sponsor | University of Southern Denmark |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 15,000 |
| Start date | 1 December 2021 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Patient reported ourcomes
Conditions studied
- Neurocognitive Disorders — all drugs for Neurocognitive Disorders →
- Post Operative Delirium — all drugs for Post Operative Delirium →
- Pain — all drugs for Pain →
- Nausea — all drugs for Nausea →
Sponsor
University of Southern Denmark
Who can join
Adults 18 to 100, any sex, with Neurocognitive Disorders or Post Operative Delirium. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Perioperatively, patients experience an unnecessarily high level of side effects associated with their treatment. These side effects include nausea, severe pain, anxiety, and stress. Moreover, many patients develop postoperative delirium (POD) and neurocognitive dysfunctions, often resulting in long-term cognitive impairment, decreased quality of life, and increased mortality. However, physicians, nurses and their institutions do not receive structured feedback regarding these aspects of each patient's well-being. They may therefore be unable to engage in the essential cause-and-effect learning necessary to evaluate and consecutively reduce such side effects. Effective guidelines conform prevention is the proven key to shielding our patients from adverse Outcomes. The Safe Brain Initiative's high-quality routine data-for-action is a sword and accelerator for moving towards patient-centred, precision care. Thus, establishing a foundation for value-based and patient-centred healthcare development. However, a turnkey real-world solution is challenging to develop and implement and requires substantial resources. As a result, such solutions are usually beyond the scope of a single institution. The SBI platform provides high-quality, real-world data to bridge this gap. It allows monitoring and in-depth analysis of cause and effect in the day-to-day routine of individuals, departments, and institutions. The SBI's approach is continuously improved and updated. An organization called the SBI Global Society oversees the quality and precision of science through experts in the field. At SBI Hospitals and Flagship centres, Masterclasses are conducted and can be attended alongside clinical immersions. SBI Solutions manages, develops, and provides technical and service support for the Safe Brain Initiative. Its service guarantees the professional and GDPR conform management of data handling and storage as well as the user-friendly functionality of the SBI-Dashboard solutions.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A first assessment of the safe brain initiative care bundle for addressing postoperative delirium in the postanesthesia care unit.
Meco BC, Jakobsen K, De Robertis E, Buhre W, et al · · 2024 · cited 11× · PMID 38972091 · DOI 10.1016/j.jclinane.2024.111506
Verify or expand the search:
- PubMed search for NCT05765162
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Southern Denmark trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05765162 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southern Denmark
- Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05765162.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing