Biomarkers and Postoperative Delirium in Elderly Patients

Relationship Between Neuroinflammatory Biomarkers and Postoperative Delirium in Elderly Patients With Hip Replacement

This study intends to verify and explore the correlation of neuroinflammation biomarkers in cerebrospinal fluid and plasma of elderly patients undergoing hip replacement with postoperative delirium, so as to achieve a new method to predict whether patients will develop postoperative delirium and improve the prognosis of elderly patients with postoperative delirium. Reduce the probability of postoperative complications, improve the long-term survival rate of patients after surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Behavioral: postoperative delirium

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Zhaoyu Wen, Bachelor; Phone Number: 0086-18860371522; Email: 76338445@qq.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan People's Hospital
      • Contact: Zhaoyu Wen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients undergoing hip replacement surgery in Henan Provincial People's Hospital were selected during the trial

Description

Inclusion Criteria:

1. age≥65
2. Patients undergoing hip replacement under spinal anesthesia
3. ASA grade I~III;
4. Voluntarily participate in this study, and informed consent was signed by the patients themselves and their families

Exclusion Criteria:

1. Patients with multiple fractures and trauma
2. Patients with preoperative cognitive dysfunction determined by MMSE scale;
3. Severe impairment of hearing, visual and language system functions;
4. Not suitable for or unwilling to undergo subarachnoid anesthesia
5. Patients who refuse to participate or cannot cooperate.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Delirium	Behavioral: postoperative delirium; Postoperative delirium (POD) occurs within 1 week after surgery in patients, with obvious time characteristics, mainly occurring within 1-3 days after surgery. Postoperative delirium has adverse effects on the short and long term prognosis of patients. Patients with delirium have an increased risk of postoperative complications, perioperative death, longer hospital stay and increased medical costs during hospitalization.
Non-delirium	Behavioral: postoperative delirium; Postoperative delirium (POD) occurs within 1 week after surgery in patients, with obvious time characteristics, mainly occurring within 1-3 days after surgery. Postoperative delirium has adverse effects on the short and long term prognosis of patients. Patients with delirium have an increased risk of postoperative complications, perioperative death, longer hospital stay and increased medical costs during hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neuroinflammatory biomarkers	Whether there are changes in neuroinflammatory biomarkers(Ykl40(pg/mL), procalcitonin(ng/mL), IL-17A,IL-23,INF-γ(IU), Tau(pg/mL), amyloid beta(pg/mL),etc) in cerebrospinal fluid and plasma between delirium patients and non-delirium patients before and after operation.	preoperative、24 hours after surgery、48 hours after surgery

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: Biomarkers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No