Analyses of Cerebrospinalfluid in Patients With Delirium | NCT05060614

Studies
Analyses of Cerebrospinalfluid in Patients With Delirium

NCT05060614

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

Mar 12, 2024Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Delirium

Interventions

Hip fracture surgery

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Dec 30, 2027Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Jun 30, 2021

First Submission Date that Met QC Criteria

Sep 28, 2021

First Posted Date

Sep 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2024

Last Update Posted Date

Mar 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

700Estimated

Name	Type	Description	Arm Group Labels	Other Names
Hip fracture surgery	Procedure	Hip fracture surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delirium	Pre- and postoperative delirium	Daily during hospital stay (pre-/and postoperatively) until 5 days after surgery (or discharge)

Secondary Outcomes

Measure	Description	Time Frame
Dementia	Incident dementia	Cognitive changes the first 48 months after inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with acute hip fracture

Exclusion Criteria:

Moribund patients.
Lack of consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients acutely admitted with a hip fracture.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leiv O Watne, PhD	Contact	40203712		l.o.watne@gmail.com

Overall Officials

Name	Affiliation	Role
Leiv O Watne, PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiv Otto Watne	Recruiting	Oslo	Other	0671	Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided