The Neuro-epigenetics Biomarkers of Postoperative Delirium in Elderly Patients Undergoing Hip/Knee Replacement

NCT04923243 | Unknown

• 1 other identifier: HBRC202004072021014
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Postoperative delirium (POD), an acute, transient, fluctuating disturbance in attention, cognition, and level of consciousness, is a common (15-53%) postoperative complication, and it is associated with longer hospital stays, worse functional outcomes, higher healthcare costs, and increased mortality. However, at the current time, effective prevention and treatment are not only hampered by lack of knowledge about the neuropathogenesis of POD but also by a lack of biomarkers that could predict individual risk and assess diagnosis and severity of POD. Recent studies have focused on inflammatory markers (IL-1, IL-6, IL-8, IL-10, CRP), Alzheimer's disease-related factors (Tau, Aβ40/42), and nerve injury factors (S100β, NSE), but failed to establishing causality between these markers and POD. Furthermore, these results were contradictory. Previous study of the investigators found that the dysregulation of preoperative microRNA (miR)-146a and miR-181c in cerebrospinal fluid (CSF) and serum was associated with the development and severity of POD. Therefore, the investigators hypothesized these neurimmiRs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of POD. Purpose: Aims to search for neuro-epigenetics biomarkers to predict and diagnose POD.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (5)

• cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine

  Cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine of the participants were measured by DNA sequencing or RNA sequencing before surgery.

  just before surgery

• genome-specific difference between POD and non-POD patients

  Compare the exon sequence in blood samples of the participants, as assessed by whole exome sequencing.

  just before surgery

• candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine

  Candidate cell-free DNA, cell-free RNA and exosomal RNA identified in the first outcome were quantified by PCR or RT-PCR on post operative day 1.

  post operative day 1

• candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine

  Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 3.

  post operative day 3

• candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine

  Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 7 or the day after delirium disappeared.

  post operative day 7 or the day after delirium disappeared

Secondary Outcomes (10)

• Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

  before surgery (from 1 week before to the day before)

• Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

  post operative day 1

• Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)

  post operative day 1

• Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)

  post operative day 1

• Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

  post operative day 3

Study Arms (2)

Delirium group

Group of patients with postoperative delirium

Procedure: hip/knee replacement

Non delirium group

Group of patients without postoperative delirium

Procedure: hip/knee replacement

Interventions

hip/knee replacement PROCEDURE

hip/knee replacement

Delirium group; Non delirium group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients were at least 65 years old and were scheduled to have hip/knee replacement.

You may not qualify if:

• a past medical history of neurological or clinically evident neurovascular disease (e.g., Alzheimer's disease, other forms of dementia, stroke);
• patients diagnosed with malignant or benign tumors;
• Mini-Mental State Examination (MMSE) scores of 26 or less;
• American Society of Anesthesiologists (ASA) score greater than 3;
• a history of alcohol abuse and drug dependence;
• inability to read or severe visual or auditory deficits;
• unwillingness to comply with the protocol or procedures.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: June 11, 2021
• Study Start: November 3, 2021
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)