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

April 28, 2023 updated by: Wen-bin Lu, MD, Changhai Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease were scheduled to undergo elective subthalamic nucleus deep brain stimulation surgery for the first time under total intravenous anesthesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The CAM questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAM score
Time Frame: 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.
Before surgery
CAM score
Time Frame: 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.
Postoperative day 1
CAM score
Time Frame: 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.
Postoperative day 2
CAM score
Time Frame: 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.
Postoperative day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-mental State Examination (MMSE) score
Time Frame: Before surgery
MMSE score ranges from 0 to 30 and higher score means better cognitive function.
Before surgery
MMSE score
Time Frame: Postoperative 24 hour
MMSE score ranges from 0 to 30 and higher score means better cognitive function.
Postoperative 24 hour
MMSE score
Time Frame: postoperative 72 hour
MMSE score ranges from 0 to 30 and higher score means better cognitive function.
postoperative 72 hour
The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.
Time Frame: Before surgery
The FAR was calculated as fibrinogen / albumin.
Before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POD-FAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe