Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833308
• Other study ID #: POD-FAR
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative delirium (POD) remains one of the most common neuropsychiatric complications after deep brain stimulation (DBS) surgery. The fibrinogen-to-albumin ratio (FAR) has been shown to significantly correlate with prognosis of many diseases associated with inflammation, but the relationship between FAR and POD is unclear. The investigators aimed to investigate the association between POD and FAR in Parkinson's disease (PD) patients receiving DBS surgery. For this aim, the present study was conducted to provide a new method for the early recognition and perioperative management of delirium after DBS surgery in PD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Over 55 years old

• American Society of Anesthesiologists (ASA) physical status I-III

• Bilateral subthalamic nucleus deep brain stimulation surgery

Exclusion Criteria:

• Preoperative delirium

• Missing preoperative laboratory parameters on fibrinogen or albumin

• Persistent infectious diseases

• Coagulopathy and autoimmune-illness or malignancies

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Delirium
• Parkinson Disease
• Postoperative Delirium

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAM score	Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.	Before surgery
Primary	CAM score	Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.	Postoperative day 1
Primary	CAM score	Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.	Postoperative day 2
Primary	CAM score	Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.	Postoperative day 3
Secondary	Mini-mental State Examination (MMSE) score	MMSE score ranges from 0 to 30 and higher score means better cognitive function.	Before surgery
Secondary	MMSE score	MMSE score ranges from 0 to 30 and higher score means better cognitive function.	Postoperative 24 hour
Secondary	MMSE score	MMSE score ranges from 0 to 30 and higher score means better cognitive function.	postoperative 72 hour
Secondary	The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.	The FAR was calculated as fibrinogen / albumin.	Before surgery