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

Completed

• Conditions: Cognitive Dysfunction; Delirium

• Registration Number: NCT05105906
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-03
• Primary Completion: 2024-05-25
• Study Completion: 2024-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Age > 65
• Clinical - radiological presence of hip fracture

Exclusion Criteria

• Age <65

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appearance of POD within the first 3 months	3 months assessment	Appearance of Post Operative Delirium within the first 3 months after hip surgery

Secondary Outcome Measures

Name	Time	Method
Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time	12 months assessment	Development of Post Operative Cognitive Dysfunction, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy