Cytokines, POD, Health Status, Older Hip Fracture

• Conditions: Older People; Postoperative Delirium; Hip Fracture Surgery

• Registration Number: NCT05096507
• Lead Sponsor: University of Nottingham

Brief Summary

An investigation of the change in inflammation marker levels across hip fracture surgery and an exploration of any association with change in self reported health status and incidence of postoperative delirium

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-10-27
• Study Start: 2022-06-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-19
• Primary Completion: 2023-05-30
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 65 years old
• Admitted for primary hip fracture surgery

Exclusion Criteria

• Preoperative cognitive impairment
• History of neurosurgery, neurologic diseases or head trauma
• Current systemic bacterial or viral infection
• Complex or multiple injuries

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytokine dynamics	2 days	Difference preoperative serum cytokine levels and postoperative serum cytokine levels in pg/mL.
Incidence of postoperative delirium	5 days	Assessment for presence or absence of delirium during the post operative period.

Secondary Outcome Measures

Name	Time	Method
Self reported health related quality of Life	120 days	Assessed preoperatively and again at approximately 120 days after surgery using the EuroQol Five Dimension Five level (EQ-5D-5L) tool. The tool assesses on five aspects of health (Dimensions) and each dimension has five possible levels. The tool also has a visual analogue scale ranging from 0 (poorest) to 100 (best health)

Trial Locations

Locations (1)

Queen's Medical Centre; 🇬🇧 Nottingham, United Kingdom