Parkinson Disease Clinical Trial
Official title:
Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease
NCT number | NCT05833308 |
Other study ID # | POD-FAR |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | January 31, 2023 |
Verified date | April 2023 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
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 |
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