NCT05060614

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2016Dec 2027

Study Start

First participant enrolled

September 1, 2016

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11.3 years

First QC Date

June 30, 2021

Last Update Submit

March 7, 2024

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Pre- and postoperative delirium

    Daily during hospital stay (pre-/and postoperatively) until 5 days after surgery (or discharge)

Secondary Outcomes (1)

  • Dementia

    Cognitive changes the first 48 months after inclusion

Interventions

Hip fracture surgeryPROCEDURE

Hip fracture surgery

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients acutely admitted with a hip fracture.

You may qualify if:

  • Patients with acute hip fracture

You may not qualify if:

  • Moribund patients.
  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiv Otto Watne

Oslo, Other, 0671, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

CSF, blood

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Leiv O Watne, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leiv O Watne, PhD

CONTACT

40203712l.o.watne@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

June 30, 2021

First Posted

September 29, 2021

Study Start

September 1, 2016

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

NO(1)