Mechanisms of Perioperative Systemic Inflammation in the Development of PND in Cirrhotic Patients

NCT ID: NCT07082946

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2025-08-31

Brief 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. 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.

Conditions

Hepatic Encephalopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with liver cirrhosis scheduled for upper abdominal surgery

No interventions assigned to this group

Patients without liver cirrhosis scheduled for upper abdominal surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age: 18-80 years

2. Patients with or without liver cirrhosis scheduled for upper abdominal surgery due to various clinical indications

3. Ability to comply with the study protocol and provide informed consent

Exclusion Criteria

1. Comorbid severe cardiac, pulmonary, or renal diseases

2. Patients with mental status incompatible with study participation, including:

• Psychiatric disorders
• Inability to communicate clearly

3. Any condition preventing effective communication or cooperation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peng Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Peng Li, MD

Role: CONTACT

lipengmazui@163.com

86+13668169590

Other Identifiers

SPPH202360

Identifier Type: -

Identifier Source: org_study_id