DeliriumNCT05060614
Analyses of Cerebrospinalfluid in Patients With Delirium
An observational study of Delirium, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The current project aims to measure biomarkers in the cerebrospinalfluid (CSF) and serum samples from patients with delirium. We hope to uncover new insights into the pathophysiology of delirium and explore its link to dementia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Hip fracture surgery
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2016to 30 Dec 2027
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients acutely admitted with a hip fracture.
Who may be able to join
- Patients with acute hip fracture
Who cannot join
- Moribund patients.
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Leiv Otto Watne
Oslo, Other, 0671
Leiv O Watne, PhD, 40203712, l.o.watne@gmail.com
Leiv Otto Watne, MD
About this study
Official title: MOLECULAR BIOMARKERS IN DELIRIUM AND DEMENTIA
The current project aims to measure biomarkers in the cerebrospinalfluid (CSF) and serum samples from patients with delirium. We hope to uncover new insights into the pathophysiology of delirium and explore its link to dementia.
Read the detailed description
Delirium is a common and serious complication to acute illness, and is characterized by acute disturbances in attention, awareness, and cognition. Dementia is a major risk factor of delirium, and delirium increases the risk of dementia progression and development. As the conditions share both clinical and epidemiological features, some researchers suggest that also pathophysiological links are shared. Understanding delirium pathophysiology, which is poorly understood, may thus help elucidate early molecular mechanisms in dementia.
This study aims to to increase our understanding of the pathophysiology of delirium and molecular links between delirium and dementia, by exploring cerebrospinal fluid (CSF) biomarkers.
- Conditions
- Delirium
- Being tested
- Hip fracture surgery
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip fracture surgeryProcedure or surgery
Hip fracture surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Pre- and postoperative delirium
Measured: Daily during hospital stay (pre-/and postoperatively) until 5 days after surgery (or discharge)
Secondary outcomes (1)
Dementia
Incident dementia
Measured: Cognitive changes the first 48 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Sep 2016
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leiv Otto Watne, Oslo University Hospital
- Investigators
- Leiv O Watne, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060614
- Sponsor's protocol ID
- 2016/1368
- Status last verified
- Mar 2024
- First submitted
- 30 Jun 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability is dependent on approval from the Regional Committee for Medical and Health Research Ethics in Norway. The data are not publicly available due to privacy or ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOLECULAR BIOMARKERS IN DELIRIUM AND DEMENTIA
- ClinicalTrials.gov ID
- NCT05060614
- Acronym / sponsor ID
- 2016/1368
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Sep 2021 (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.
The current project aims to measure biomarkers in the cerebrospinalfluid (CSF) and serum samples from patients with delirium. We hope to uncover new insights into the pathophysiology of delirium and explore its link to dementia.
Detailed description
Delirium is a common and serious complication to acute illness, and is characterized by acute disturbances in attention, awareness, and cognition. Dementia is a major risk factor of delirium, and delirium increases the risk of dementia progression and development. As the conditions share both clinical and epidemiological features, some researchers suggest that also pathophysiological links are shared. Understanding delirium pathophysiology, which is poorly understood, may thus help elucidate early molecular mechanisms in dementia.
This study aims to to increase our understanding of the pathophysiology of delirium and molecular links between delirium and dementia, by exploring cerebrospinal fluid (CSF) biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients acutely admitted with a hip fracture.
Key inclusion criteria (1 listed)
- Patients with acute hip fracture
Key exclusion criteria (2 listed)
- Moribund patients.
- Lack of consent
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 |
|---|---|---|
| Hip fracture surgeryHip fracture surgery | Procedure or surgery | – |
Primary outcome
Delirium
Time frame: Daily during hospital stay (pre-/and postoperatively) until 5 days after surgery (or discharge)
Pre- and postoperative delirium
1 secondary outcome
Dementia
Time frame: Cognitive changes the first 48 months after inclusion
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 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. Availability is dependent on approval from the Regional Committee for Medical and Health Research Ethics in Norway. The data are not publicly available due to privacy or ethical restrictions.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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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.
Leiv O Watne, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 2 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 12 Mar 2024. 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 Norway. 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 Leiv O Watne, PhD (40203712, l.o.watne@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Daily during hospital stay (pre-/and postoperatively) until 5 days after surgery (or discharge)). 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 12 Mar 2024.