Cytokines, POD, Health Status, Older Hip Fracture
Perioperative Cytokines, Postoperative Delirium and Health Status in Older People Undergoing Hip Fracture Surgery - a Pilot Study
1 other identifier
observational
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedStudy Start
First participant enrolled
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedAugust 19, 2022
August 1, 2022
12 months
October 5, 2021
August 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cytokine dynamics
Difference preoperative serum cytokine levels and postoperative serum cytokine levels in pg/mL.
2 days
Incidence of postoperative delirium
Assessment for presence or absence of delirium during the post operative period.
5 days
Secondary Outcomes (1)
Self reported health related quality of Life
120 days
Study Arms (1)
Study group
People age 65 years and older undergoing primary hip fracture surgery
Interventions
Surgery for primary hip fracture requiring general or neuro-axial anaesthesia
Eligibility Criteria
Patients age ≥ 65 years old presenting to hospital with a primary hip fracture
You may qualify if:
- Age ≥ 65 years old
- Admitted for primary hip fracture surgery
You may not qualify if:
- Preoperative cognitive impairment
- History of neurosurgery, neurologic diseases or head trauma
- Current systemic bacterial or viral infection
- Complex or multiple injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen's Medical Centre
Nottingham, United Kingdom
Biospecimen
Blood sample for Cytokine analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iain Moppett, DM
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
October 27, 2021
Study Start
June 6, 2022
Primary Completion
May 30, 2023
Study Completion
July 31, 2023
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share