Hepatic EncephalopathyNCT07082946
Mechanisms of Perioperative Systemic Inflammation in the Development of PND in Cirrhotic Patients
An observational study of Hepatic Encephalopathy, run by Sichuan Provincial People's Hospital.
Trial summary
Chronic Liver Disease (CLD) is associated with significant cognitive dysfunction, including hepatic encephalopathy (HE), which is driven by systemic inflammation and blood-brain barrier (BBB) disruption. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2025to 31 Aug 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients scheduled for surgical treatment at Sichuan Provincial People's Hospital.
Who may be able to join
- Age: 18-80 years
- Patients with or without liver cirrhosis scheduled for upper abdominal surgery due to various clinical indications
- Ability to comply with the study protocol and provide informed consent
Who cannot join
- Comorbid severe cardiac, pulmonary, or renal diseases
- Patients with mental status incompatible with study participation, including:
- Psychiatric disorders
- Inability to communicate clearly
- Any condition preventing effective communication or cooperation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mechanism of Perioperative Systemic Inflammation-Induced Postoperative Neurocognitive Disorders in Chronic Liver Disease Patients Via Blood-Brain Barrier Disruption
Chronic Liver Disease (CLD) is associated with significant cognitive dysfunction, including hepatic encephalopathy (HE), which is driven by systemic inflammation and blood-brain barrier (BBB) disruption. Perioperative Neurocognitive Disorders (PND), comprising postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), further exacerbate these impairments, particularly in cirrhotic patients undergoing major surgery. However, the mechanisms linking systemic inflammation, BBB dysfunction, and PND remain poorly understood. This study aimed to investigate perioperative cognitive changes and inflammatory markers in cirrhotic and non-cirrhotic patients undergoing major abdominal surgery, and to explore the effects of cirrhosis and surgical intervention on central nervous system inflammation and cognitive dysfunction using a rat model. The investigators conducted a prospective study on cirrhotic and non-cirrhotic patients undergoing major abdominal surgery. Perioperative cognitive function was assessed using validated tools, and inflammatory markers were analyzed using Olink Target protein detection and bioinformatics approaches. Additionally, the investigators established a cirrhosis model using bile duct ligation (CBDL) in rats, followed by exploratory laparotomy to evaluate behavioral performance, BBB integrity and levels of inflammatory cytokines in serum and brain tissue.
Read the detailed description
Chronic Liver Disease (CLD) is associated with significant cognitive dysfunction, including hepatic encephalopathy (HE), which is driven by systemic inflammation and blood-brain barrier (BBB) disruption. Perioperative Neurocognitive Disorders (PND), comprising postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), further exacerbate these impairments, particularly in cirrhotic patients undergoing major surgery. However, the mechanisms linking systemic inflammation, BBB dysfunction, and PND remain poorly understood. This study aimed to investigate perioperative cognitive changes and inflammatory markers in cirrhotic and non-cirrhotic patients undergoing major abdominal surgery, and to explore the effects of cirrhosis and surgical intervention on central nervous system inflammation and cognitive dysfunction using a rat model. The investigators conducted a prospective study on cirrhotic and non-cirrhotic patients undergoing major abdominal surgery. Perioperative cognitive function was assessed using validated tools, and inflammatory markers were analyzed using Olink Target protein detection and bioinformatics approaches. Additionally, the investigators established a cirrhosis model using bile duct ligation (CBDL) in rats, followed by exploratory laparotomy to evaluate behavioral performance, BBB integrity and levels of inflammatory cytokines in serum and brain tissue.
- Conditions
- Hepatic Encephalopathy
- Medical subject headings
- Hepatic Encephalopathy
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 |
|---|---|---|
| Patients with liver cirrhosis scheduled for upper abdominal surgery | Not described | |
| Patients without liver cirrhosis scheduled for upper abdominal surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium within 7 days after upper abdominal surgery in patients with liver cirrhosis
Measured: within 7 days after sugery
Secondary outcomes (1)
The incidence of postoperative delirium within 7 days after upper abdominal surgery in patients without liver cirrhosis
Measured: within 7 days after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 148 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082946
- Sponsor's protocol ID
- SPPH202360
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Perioperative Systemic Inflammation-Induced Postoperative Neurocognitive Disorders in Chronic Liver Disease Patients Via Blood-Brain Barrier Disruption
- ClinicalTrials.gov ID
- NCT07082946
- Acronym / sponsor ID
- SPPH202360
- Conditions
- Hepatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Jul 2025 (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.
Chronic Liver Disease (CLD) is associated with significant cognitive dysfunction, including hepatic encephalopathy (HE), which is driven by systemic inflammation and blood-brain barrier (BBB) disruption. Perioperative Neurocognitive Disorders (PND), comprising postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), further exacerbate these impairments, particularly in cirrhotic patients undergoing major surgery. However, the mechanisms linking systemic inflammation, BBB dysfunction, and PND remain poorly understood. This study aimed to investigate perioperative cognitive changes and inflammatory markers in cirrhotic and non-cirrhotic patients undergoing major abdominal surgery, and to explore the effects of cirrhosis and surgical intervention on central nervous system inflammation and cognitive dysfunction using a rat model. The investigators conducted a prospective study on cirrhotic and non-cirrhotic patients undergoing major abdominal surgery. Perioperative cognitive function was assessed using validated tools, and inflammatory markers were analyzed using Olink Target protein detection and bioinformatics approaches. Additionally, the investigators established a cirrhosis model using bile duct ligation (CBDL) in rats, followed by exploratory laparotomy to evaluate behavioral performance, BBB integrity and levels of inflammatory cytokines in serum and brain tissue.
Detailed description
Chronic Liver Disease (CLD) is associated with significant cognitive dysfunction, including hepatic encephalopathy (HE), which is driven by systemic inflammation and blood-brain barrier (BBB) disruption. Perioperative Neurocognitive Disorders (PND), comprising postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), further exacerbate these impairments, particularly in cirrhotic patients undergoing major surgery. However, the mechanisms linking systemic inflammation, BBB dysfunction, and PND remain poorly understood. This study aimed to investigate perioperative cognitive changes and inflammatory markers in cirrhotic and non-cirrhotic patients undergoing major abdominal surgery, and to explore the effects of cirrhosis and surgical intervention on central nervous system inflammation and cognitive dysfunction using a rat model. The investigators conducted a prospective study on cirrhotic and non-cirrhotic patients undergoing major abdominal surgery. Perioperative cognitive function was assessed using validated tools, and inflammatory markers were analyzed using Olink Target protein detection and bioinformatics approaches. Additionally, the investigators established a cirrhosis model using bile duct ligation (CBDL) in rats, followed by exploratory laparotomy to evaluate behavioral performance, BBB integrity and levels of inflammatory cytokines in serum and brain tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis scheduled for upper abdominal surgery | – | – |
| Patients without liver cirrhosis scheduled for upper abdominal surgery | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients scheduled for surgical treatment at Sichuan Provincial People's Hospital.
Key inclusion criteria (3 listed)
- Age: 18-80 years
- Patients with or without liver cirrhosis scheduled for upper abdominal surgery due to various clinical indications
- Ability to comply with the study protocol and provide informed consent
Key exclusion criteria (5 listed)
- Comorbid severe cardiac, pulmonary, or renal diseases
- Patients with mental status incompatible with study participation, including:
- Any condition preventing effective communication or cooperation
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
The incidence of postoperative delirium within 7 days after upper abdominal surgery in patients with liver cirrhosis
Time frame: within 7 days after sugery
1 secondary outcome
The incidence of postoperative delirium within 7 days after upper abdominal surgery in patients without liver cirrhosis
Time frame: within 7 days after sugery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy, run by Sichuan Provincial People's Hospital.
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 5 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: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Li, MD (86+13668169590, lipengmazui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium within 7 days after upper abdominal surgery in patients with liver cirrhosis (time frame: within 7 days after sugery). 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 24 Jul 2025.