Biomarkers and Postoperative Delirium in Elderly Patients

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454228
• Other study ID #: biomarkers
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Henan Provincial People's Hospital
• Contact: Zhaoyu Wen, Bachelor
• Phone: 0086-18860371522
• Email: 76338445[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
China	Henan People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuroinflammatory biomarkers	Whether there are changes in neuroinflammatory biomarkers(Ykl40(pg/mL), procalcitonin(ng/mL), IL-17A,IL-23,INF-?(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