Parkinson DiseaseNCT05833308
Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease
An observational study of Parkinson Disease and Deep Brain Stimulation, run by Changhai Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation, Postoperative Delirium
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Over 55 years old
- American Society of Anesthesiologists (ASA) physical status I-III
- Bilateral subthalamic nucleus deep brain stimulation surgery
Who cannot join
- Preoperative delirium
- Missing preoperative laboratory parameters on fibrinogen or albumin
- Persistent infectious diseases
- Coagulopathy and autoimmune-illness or malignancies
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- postoperative delirium, fibrinogen-to-albumin ratio
- Medical subject headings
- Parkinson Disease, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery
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.
Measured: Postoperative day 1
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.
Measured: Postoperative day 2
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.
Measured: Postoperative day 3
Secondary outcomes (4)
Mini-mental State Examination (MMSE) score
MMSE score ranges from 0 to 30 and higher score means better cognitive function.
Measured: Before surgery
MMSE score
MMSE score ranges from 0 to 30 and higher score means better cognitive function.
Measured: Postoperative 24 hour
MMSE score
MMSE score ranges from 0 to 30 and higher score means better cognitive function.
Measured: postoperative 72 hour
The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.
The FAR was calculated as fibrinogen / albumin.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-bin Lu, MD, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833308
- Sponsor's protocol ID
- POD-FAR
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05833308
- Acronym / sponsor ID
- POD-FAR
- Keywords
- postoperative delirium, fibrinogen-to-albumin ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Over 55 years old
- American Society of Anesthesiologists (ASA) physical status I-III
- Bilateral subthalamic nucleus deep brain stimulation surgery
Key exclusion criteria (4 listed)
- Preoperative delirium
- Missing preoperative laboratory parameters on fibrinogen or albumin
- Persistent infectious diseases
- Coagulopathy and autoimmune-illness or malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Mini-mental State Examination (MMSE) score
Time frame: Before surgery
MMSE score
Time frame: Postoperative 24 hour
MMSE score
Time frame: postoperative 72 hour
The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.
Time frame: Before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Deep Brain Stimulation, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAM score (time frame: Before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.