Biomarkers and Postoperative Delirium in Elderly Patients

NCT05454228 | Unknown

• 1 other identifier: biomarkers
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Delirium

Behavioral: postoperative delirium

Non-delirium

Behavioral: postoperative delirium

Interventions

postoperative delirium BEHAVIORAL

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.

Delirium; Non-delirium

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan People's Hospital

Zhengzhou, Henan, 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

Central Study Contacts

Zhaoyu Wen, Bachelor

CONTACT

0086-18860371522; 76338445@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 12, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2023

Record last verified: 2022-06

Locations

CN (1)