Analyses of Cerebrospinalfluid in Patients With Delirium

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium
• Intervention / Treatment: Procedure: Hip fracture surgery

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 Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Leiv O Watne, PhD; Phone Number: 40203712; Email: l.o.watne@gmail.com

Study Locations

• Norway
  • Other
    • Oslo, Other, Norway, 0671
      • Recruiting
      • Leiv Otto Watne
      • Contact: Leiv O Watne, PhD; Phone Number: 40203712; Email: l.o.watne@gmail.com
      • Principal Investigator: Leiv Otto Watne, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients acutely admitted with a hip fracture.

Description

Inclusion Criteria:

• Patients with acute hip fracture

Exclusion Criteria:

• Moribund patients.
• Lack of consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Leiv O Watne, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2016/1368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No