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NCT05096507 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
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