Cytokines, POD, Health Status, Older Hip Fracture

• Sponsor: University of Nottingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05096507
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 13.8
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium; Hip Fracture Surgery; Older People	Procedure: Hip fracture Surgery (Primary)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Perioperative Cytokines, Postoperative Delirium and Health Status in Older People Undergoing Hip Fracture Surgery - a Pilot Study
• Actual Study Start Date: Jun 6, 2022
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study group People age 65 years and older undergoing primary hip fracture surgery	Procedure: Hip fracture Surgery (Primary); Surgery for primary hip fracture requiring general or neuro-axial anaesthesia

Outcome Measures

Primary Outcome Measures

1. Cytokine dynamics [2 days]

   Difference preoperative serum cytokine levels and postoperative serum cytokine levels in pg/mL.

2. Incidence of postoperative delirium [5 days]

   Assessment for presence or absence of delirium during the post operative period.

Secondary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen's Medical Centre	Nottingham		United Kingdom

Sponsors and Collaborators

• University of Nottingham

Investigators

• Principal Investigator: Iain Moppett, DM, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT05096507
• Other Study ID Numbers: 21052
• First Posted: Oct 27, 2021
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Nottingham: Postoperative delirium; Older people; Cytokines; Self-reported Health Status
• Additional relevant MeSH terms: Delirium; Fractures, Bone; Hip Fractures

Study Results

No Results Posted as of Aug 19, 2022