Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty

October 5, 2022 updated by: Xuzhou Central Hospital

Peripheral Blood Single Cell Sequencing Analysis of Postoperative Delirium (POD) and Chronic Postsurgical Pain (CPSP) in Elderly Patients After Total Knee Arthroplasty

Single-celled sequencing for evaluating differences in gene expression patterns in different cell types of the dynamics of a means of this research as a starting point, to study the postoperative delirium and chronic pain at the cellular level changes the contents of a cell, reveal its occurrence and development of the role of gene regulation, find targets and biomarkers, and to provide new ideas for its pathogenesis, To provide theoretical basis support for its prevention, clinical diagnosis and treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The aim of this study was to investigate leukocyte heterogeneity in patients undergoing total knee arthroplasty with POD, paired non-POD patients, and cognitively normal healthy subjects by single cell sequencing, and to investigate leukocyte heterogeneity in patients with chronic pain and patients with pain relief after surgery through postoperative pain follow-up. Moreover, multi-omics single cell technology is used to analyze various cellular contents in a single cell simultaneously, which can capture molecular footprints with higher resolution. Comprehensive analysis of multiple omics datasets reveals the relationships between cellular patterns, establishes complex regulatory networks, and provides a holistic view of cellular state. From a single cell level analysis of POD and occurred in patients with chronic pain in patients with the characteristics of the white blood cells, looking for the peripheral immune system in the pathogenesis of the POD and the potential role of chronic pain occurs, may provide POD pathogenesis and chronic pain occurred an important visual Angle, may also help to provide POD biomarkers and therapeutic targets, To provide a possible solution for the prevention and treatment of postoperative delirium and postoperative chronic pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective total knee replacement.

Description

Inclusion Criteria:

  • Age ≥65 years old, regardless of gender.
  • total knee arthroplasty for the first time.
  • The ASA classification is I-Ⅲ.

Exclusion Criteria:

  • severe neurological or psychiatric disorders
  • drug and alcohol abuse
  • patients on antidepressants
  • failure and decompensation of vital organs
  • chronic pain from previous surgery or trauma

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
POD group
According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
non-POD group
According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
CPSP group
Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain
non-CSP group
Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference of single cell sequencing before and after surgery
Time Frame: 1 day before surgery，1 day after surgery
Leukocytes were isolated from peripheral blood and then sorted for subsequent single-cell sequencing analysis. Unbiased, high-throughput and high-resolution transcriptome analysis of single cells can reveal the gene structure and gene expression status of single cells, reflect the heterogeneity between cells, classify and analyze them, and carry out personalized research
1 day before surgery，1 day after surgery
3-minute Diagnostic Interview for CAM (3D-CAM)
Time Frame: Consecutive 7 days after the surgery
Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).
Consecutive 7 days after the surgery
Visual analogue scale（VAS）
Time Frame: 3 months after the surgery
A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured.
3 months after the surgery
Short form McGill pain questionnaire（SF-MPQ）
Time Frame: 3 months after the surgery
SF-MPQ is composed of sensory and emotional descriptors of pain, current pain intensity and visual analogue scale.
3 months after the surgery
Leeds Assessment of Neuropathic Symptoms and Signs（LANSS）
Time Frame: 3 months after the surgery
Make the needle perpendicular to the patient's skin, and apply different pressure on the skin to determine whether the patient has touch-induced pain.
3 months after the surgery
Pain catastrophizing scale(PCS)
Time Frame: 3 months after the surgery
PCS is defined as a belief system, a coping strategy and an evaluation process when experiencing and feeling pain.
3 months after the surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuzhou Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Hospital of Xuzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Junli Cao, Doctor, Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University
  • Study Chair: Daqing Ma, Doctor, Imperial College London, Chelsea and Westminster Hospital

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 (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XuzhouCH20221010

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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