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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05833308
• Collaborator: (none)
• Enrollment: 226
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Deep Brain Stimulation; Postoperative Delirium

Study Design

• Study Type: Observational
• Actual Enrollment: 226 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jan 31, 2023
• Actual Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
POD group Patients who were determined to have incident postoperative delirium by a positive confusion assessment method (CAM) questionnaire after operation were defined as the POD group.
Non-POD group Patients who did not suffer from delirium after surgery consisted of the Non-POD group.

Outcome Measures

Primary Outcome Measures

1. CAM score [Before surgery]

   Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

2. CAM score [Postoperative day 1]

   Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

3. CAM score [Postoperative day 2]

   Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

4. CAM score [Postoperative day 3]

   Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

Secondary Outcome Measures

1. Mini-mental State Examination (MMSE) score [Before surgery]

   MMSE score ranges from 0 to 30 and higher score means better cognitive function.

2. MMSE score [Postoperative 24 hour]

   MMSE score ranges from 0 to 30 and higher score means better cognitive function.

3. MMSE score [postoperative 72 hour]

   MMSE score ranges from 0 to 30 and higher score means better cognitive function.

4. The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood. [Before surgery]

   The FAR was calculated as fibrinogen / albumin.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital	Shanghai	Shanghai	China	200433

Sponsors and Collaborators

• Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wen-bin Lu, MD, Principal Investigator, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT05833308
• Other Study ID Numbers: POD-FAR
• First Posted: Apr 27, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wen-bin Lu, MD, Principal Investigator, Changhai Hospital: postoperative delirium; fibrinogen-to-albumin ratio
• Additional relevant MeSH terms: Parkinson Disease; Delirium

Study Results

No Results Posted as of May 1, 2023