Cytokines, POD, Health Status, Older Hip Fracture

Postoperative Delirium Clinical Trial

Official title:

Perioperative Cytokines, Postoperative Delirium and Health Status in Older People Undergoing Hip Fracture Surgery - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05096507
• Other study ID #: 21052
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2022
• Source: University of Nottingham
• Contact: Abiodun Noah, FRCA
• Phone: 01158231011
• Email: abi.noah[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Fractures, Bone
• Hip Fracture Surgery
• Hip Fractures
• Older People
• Postoperative Delirium

Intervention

Procedure:
• Hip fracture Surgery (Primary)
Surgery for primary hip fracture requiring general or neuro-axial anaesthesia

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine dynamics	Difference preoperative serum cytokine levels and postoperative serum cytokine levels in pg/mL.	2 days
Primary	Incidence of postoperative delirium	Assessment for presence or absence of delirium during the post operative period.	5 days
Secondary	Self reported health related quality of Life	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)	120 days