Hip FracturesNCT05446181
CLIC1 in Patients Presenting PD
An observational study of Hip Fractures and Hip Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, mononuclear cells, particularly monocytes, were collected from the peripheral blood of elderly patients who underwent orthopedic hip surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Hip Disease
- What is being tested?
- Perioperative delirium and Hip surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2022to 30 Oct 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 undergoing hip joint surgery are divided into the PD group or non-PD group
Who may be able to join
- Male or female patients aged 65 years or older who are scheduled to undergo surgery for an orthopedic hip fracture under spinal anesthesia
Who cannot join
- Patients who are unconscious
- Patients who are unable to communicate
- Alzheimer
- Parkinson Disease
- Conversion to general anesthesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Accumulation of Chloride Intracellular Channel 1 (CLIC1) Protein in Circulating Monocyte in Elderly Patients Presenting Postoperative Delirium and Its Predictable Role of Postoperative Delirium
In this study, mononuclear cells, particularly monocytes, were collected from the peripheral blood of elderly patients who underwent orthopedic hip surgery under spinal anesthesia. We then observe the accumulation of chloride intracellular channel 1 (CLIC1), particularly the characteristic accumulation morphology and its function. The purpose of this study is to compare whether there is a difference in the degree and form of cytoplasmic CLIC1 accumulation between the elderly group with postoperative delirium (PD) and the elderly group without postoperative delirium. We'll also confirm whether this is appropriate as a predictor of postoperative delirium. In addition, we will establish a control group for the non-elderly group to check the difference due to aging itself.
- Conditions
- Hip Fractures, Hip Disease
- Being tested
- Perioperative delirium, Hip surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative deliriumBehavioural
Perioperative delirium
Hip surgeryProcedure or surgery
Orthopedic hip joint surgery under spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Old with perioperative delirium | Not described Receives: Behavioral: Perioperative delirium; Procedure: Hip surgery | |
| Old without perioperative delirium | Not described Receives: Procedure: Hip surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression pattern of CLIC1 protein
Measured: Immediate after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start27 Jun 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446181
- Sponsor's protocol ID
- B-2109-706-302
- Status last verified
- Nov 2024
- First submitted
- 1 Jul 2022
- Last updated
- 27 Nov 2024
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accumulation of Chloride Intracellular Channel 1 (CLIC1) Protein in Circulating Monocyte in Elderly Patients Presenting Postoperative Delirium and Its Predictable Role of Postoperative Delirium
- ClinicalTrials.gov ID
- NCT05446181
- Acronym / sponsor ID
- B-2109-706-302
- Conditions
- Hip Fractures, Hip Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 6 Jul 2022 (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.
In this study, mononuclear cells, particularly monocytes, were collected from the peripheral blood of elderly patients who underwent orthopedic hip surgery under spinal anesthesia. We then observe the accumulation of chloride intracellular channel 1 (CLIC1), particularly the characteristic accumulation morphology and its function. The purpose of this study is to compare whether there is a difference in the degree and form of cytoplasmic CLIC1 accumulation between the elderly group with postoperative delirium (PD) and the elderly group without postoperative delirium. We'll also confirm whether this is appropriate as a predictor of postoperative delirium. In addition, we will establish a control group for the non-elderly group to check the difference due to aging itself.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old with perioperative delirium | – | Behavioral: Perioperative delirium, Procedure: Hip surgery |
| Old without perioperative delirium | – | Procedure: Hip surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing hip joint surgery are divided into the PD group or non-PD group
Key inclusion criteria (1 listed)
- Male or female patients aged 65 years or older who are scheduled to undergo surgery for an orthopedic hip fracture under spinal anesthesia
Key exclusion criteria (5 listed)
- Patients who are unconscious
- Patients who are unable to communicate
- Alzheimer
- Parkinson Disease
- Conversion to general anesthesia
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 |
|---|---|---|
| Perioperative deliriumPerioperative delirium | Behavioural | Old with perioperative delirium |
| Hip surgeryOrthopedic hip joint surgery under spinal anesthesia | Procedure or surgery | Old with perioperative delirium, Old without perioperative delirium |
Primary outcome
expression pattern of CLIC1 protein
Time frame: Immediate after spinal anesthesia
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 27 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Fractures and Hip Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 5 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 27 Nov 2024. 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 South Korea. 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?
expression pattern of CLIC1 protein (time frame: Immediate after spinal anesthesia). 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 27 Nov 2024.