Postoperative DeliriumNCT05096507
Cytokines, POD, Health Status, Older Hip Fracture
An observational study of Postoperative Delirium and Hip Fracture Surgery, run by University of Nottingham at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Hip Fracture Surgery, Older People
- What is being tested?
- Hip fracture Surgery (Primary)
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients age ≥ 65 years old presenting to hospital with a primary hip fracture
Who may be able to join
- Age ≥ 65 years old
- Admitted for primary hip fracture surgery
Who cannot join
- Preoperative cognitive impairment
- History of neurosurgery, neurologic diseases or head trauma
- Current systemic bacterial or viral infection
- Complex or multiple injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Postoperative Delirium, Hip Fracture Surgery, Older People
- Being tested
- Hip fracture Surgery (Primary)
- Keywords
- Postoperative delirium, Older people, Cytokines, Self-reported Health Status
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip fracture Surgery (Primary)Procedure or surgery
Surgery for primary hip fracture requiring general or neuro-axial anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Study group | People age 65 years and older undergoing primary hip fracture surgery Receives: Procedure: Hip fracture Surgery (Primary) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine dynamics
Difference preoperative serum cytokine levels and postoperative serum cytokine levels in pg/mL.
Measured: 2 days
Incidence of postoperative delirium
Assessment for presence or absence of delirium during the post operative period.
Measured: 5 days
Secondary outcomes (1)
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)
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start6 Jun 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iain Moppett, DM, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096507
- Sponsor's protocol ID
- 21052
- Status last verified
- May 2026
- First submitted
- 5 Oct 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Cytokines, Postoperative Delirium and Health Status in Older People Undergoing Hip Fracture Surgery - a Pilot Study
- ClinicalTrials.gov ID
- NCT05096507
- Acronym / sponsor ID
- 21052
- Conditions
- Postoperative Delirium, Hip Fracture Surgery, Older People
- Keywords
- Postoperative delirium, Older people, Cytokines, Self-reported Health Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Hip fracture Surgery (Primary)People age 65 years and older undergoing primary hip fracture surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients age ≥ 65 years old presenting to hospital with a primary hip fracture
Key inclusion criteria (2 listed)
- Age ≥ 65 years old
- Admitted for primary hip fracture surgery
Key exclusion criteria (4 listed)
- Preoperative cognitive impairment
- History of neurosurgery, neurologic diseases or head trauma
- Current systemic bacterial or viral infection
- Complex or multiple injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip fracture Surgery (Primary)Surgery for primary hip fracture requiring general or neuro-axial anaesthesia | Procedure or surgery | Study group |
Primary outcome
Cytokine dynamics
Time frame: 2 days
Difference preoperative serum cytokine levels and postoperative serum cytokine levels in pg/mL.
Incidence of postoperative delirium
Time frame: 5 days
Assessment for presence or absence of delirium during the post operative period.
1 secondary outcome
Self reported health related quality of Life
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain Moppett, DM principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Hip Fracture Surgery, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine dynamics (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.