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NCT Number: NCT07082946

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. The incidence of postoperative delirium within 7 days after upper abdominal surgery in patients with liver cirrhosis

    Time frame: 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

    Time frame: within 7 days after sugery

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Li, MD

CONTACT

[email protected]

86+13668169590

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Mechanism of Perioperative Systemic Inflammation-Induced Postoperative Neurocognitive Disorders in Chronic Liver Disease Patients Via Blood-Brain Barrier Disruption

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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