Cytokines, POD, Health Status, Older Hip Fracture

August 16, 2022 updated by: University of Nottingham

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients age ≥ 65 years old presenting to hospital with a primary hip fracture

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported health related quality of Life
Time Frame: 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)
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2022

Primary Completion (ANTICIPATED)

May 30, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (ACTUAL)

October 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21052 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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