- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446181
CLIC1 in Patients Presenting PD
August 1, 2022 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
90
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
- Name: Hyo-Seok Na
- Phone Number: 821087012913
- Email: hsknana@naver.com
Study Locations
-
-
Gyeonggi
-
Seongnam, Gyeonggi, Korea, Republic of, 463-707
- Recruiting
- Seoul National Univ. Bundang Hospital
-
-
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
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing hip joint surgery are divided into the old group and the young group.
The old group is further divided into the old with PD group and the old without PD.
Description
Inclusion Criteria:
- Old group: Male or female patients aged 65 years or older who are scheduled to undergo surgery for an orthopedic hip fracture under spinal anesthesia
- Young group: Male or female patients between 20 and 50 years of age who are scheduled to undergo orthopedic hip joint surgery under spinal anesthesia
Exclusion Criteria:
- Patients who are unconscious
- Patients who are unable to communicate
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 |
---|---|
Old with postoperative delirium
|
Postoperative delirium
Orthopedic hip joint surgery under spinal anesthesia
|
Old without postoperative delirium
|
Orthopedic hip joint surgery under spinal anesthesia
|
Young
|
Orthopedic hip joint surgery under spinal anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
expression pattern of CLIC1 protein
Time Frame: Immediate after spinal anesthesia
|
Immediate after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 27, 2022
Primary Completion (ANTICIPATED)
June 30, 2023
Study Completion (ANTICIPATED)
June 30, 2023
Study Registration Dates
First Submitted
July 1, 2022
First Submitted That Met QC Criteria
July 1, 2022
First Posted (ACTUAL)
July 6, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 3, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2109-706-302
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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