NCT05446181

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

July 1, 2022

Last Update Submit

November 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • expression pattern of CLIC1 protein

    Immediate after spinal anesthesia

Study Arms (2)

Old with perioperative delirium

Behavioral: Perioperative deliriumProcedure: Hip surgery

Old without perioperative delirium

Procedure: Hip surgery

Interventions

Perioperative delirium

Old with perioperative delirium
Hip surgeryPROCEDURE

Orthopedic hip joint surgery under spinal anesthesia

Old with perioperative deliriumOld without perioperative delirium

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing hip joint surgery are divided into the PD group or non-PD group

You may qualify if:

  • Male or female patients aged 65 years or older who are scheduled to undergo surgery for an orthopedic hip fracture under spinal anesthesia

You may not qualify if:

  • Patients who are unconscious
  • Patients who are unable to communicate
  • Alzheimer
  • Parkinson Disease
  • Conversion to general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

June 27, 2022

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations