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NCT05105906 Clinical Trial

Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery

Delirium Clinical Trial

Official title:
Post-operative Delirium (POD) Assessment in Patients Undergoing Hip Fracture Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05105906
Other study ID # FPG ID 3993
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date June 30, 2024

Study information
Verified date February 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Giuliano Ferrone, MD
Phone +393397573088
Email giulianoferrone@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months. The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life

Recruitment information / eligibility
Status Recruiting
Enrollment 270
Est. completion date June 30, 2024
Est. primary completion date May 25, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age > 65 - Clinical - radiological presence of hip fracture Exclusion Criteria: - Age <65

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• cognitive tests performed
cognitive tests performed

Locations
Country Name City State
Italy Fondazione Policlinico Gemelli Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Appearance of POD within the first 3 months Appearance of Post Operative Delirium within the first 3 months after hip surgery 3 months assessment
Secondary Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time Development of Post Operative Cognitive Dysfunction, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time 12 months assessment
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