Liver CirrhosisNCT07012434
Exploring the Mechanisms of Postoperative Delirium in Cirrhotic Patients Through Multi-Omics Integrative Analysis
An observational study of Liver Cirrhosis, run by Sichuan Provincial People's Hospital.
Trial summary
This study looks at memory problems after surgery in people with liver disease. We want to know how often these problems happen and what might cause them. The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 30 Oct 2025
- 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: Exploring the Mechanisms of Postoperative Delirium in Cirrhotic Patients Through Multi-Omics Integrative Analysis: An Observational Study
This study looks at memory problems after surgery in people with liver disease. We want to know how often these problems happen and what might cause them. The main question it aims to answer is:
- Do people with liver disease have more memory problems after stomach surgery than people without liver disease? If yes, how much more often?
- Are changes in stomach bacteria and body chemicals related to these memory problems?
Read more
Who can join:
- Adults getting stomach surgery
- Both people with and without liver disease
What participants will do:
- Take memory tests before and after surgery
- Give stool (poop) and blood samples before and after surgery
Why this matters:
Memory problems after surgery can make recovery harder. If we find that stomach bacteria or body chemicals are involved, doctors might find new ways to prevent these problems in people with liver disease.
Read the detailed description
Liver cirrhosis is one of the most prevalent global diseases, ranking as the 11th leading cause of death worldwide with approximately 1 million annual fatalities. China has an estimated 300 million patients with liver diseases, including 7 million cirrhosis cases, accounting for 11% of global cirrhosis-related mortality. Previous studies report that approximately 1 in 10 cirrhosis patients require hepatic or non-hepatic surgical interventions during their final two years of life. With advancements in perioperative techniques including surgery, anesthesia, critical care, and nursing, non-hepatic surgeries for cirrhotic patients have become increasingly common.
The major postoperative complications in cirrhotic patients include coma, hepatic failure, sepsis, hemorrhage, thrombosis, and renal failure, among which coma represents the most frequent complication. These findings highlight the critical scientific importance of reducing postoperative complications in cirrhotic patients, particularly neurological complications.
Postoperative delirium (POD) refers to delirium occurring within one week after surgical procedures, with characteristic temporal features predominantly manifesting 24-72 hours postoperation. POD adversely impacts both short- and long-term patient outcomes. Studies demonstrate that POD patients face 2-3 times higher risk of other postoperative complications, 2-3 times increased perioperative mortality risk and prolonged hospitalization. Long-term follow-up studies reveal that POD patients exhibit increased incidence of postoperative cognitive dysfunction, reduced quality of life and higher long-term mortality rates. Cirrhotic patients frequently present with overt or subclinical cognitive impairment. Surgical intervention in this population may exacerbate neurological dysfunction, potentially explaining the significantly elevated risk of postoperative neurological complications. The commonly observed gut microbiota dysbiosis and metabolic disturbances in cirrhotic patients may play pivotal roles in this process.
This study aims to compare POD incidence and perioperative cognitive function changes between cirrhotic and non-cirrhotic patients undergoing upper abdominal surgery, and investigate the role of gut microbiota dysbiosis and metabolic abnormalities in POD pathogenesis among cirrhotic patients through integrated microbiome-metabolome analysis. The findings may provide valuable insights into the mechanisms and potential therapeutic approaches for cognitive dysfunction in cirrhotic patients.
- Conditions
- Liver Cirrhosis
- Keywords
- Postoperative delirium, gut microbiota dysbiosis, metabolomics
- Medical subject headings
- Liver Cirrhosis, 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 |
|---|---|---|
| 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 posted10 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
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
- NCT07012434
- Sponsor's protocol ID
- SPPH2025381
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the subsequent metabolomics or gut microbiome analyses yield particularly significant findings, these data may initially remain unpublished as they could require further validation through basic animal experiments.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanisms of Postoperative Delirium in Cirrhotic Patients Through Multi-Omics Integrative Analysis: An Observational Study
- ClinicalTrials.gov ID
- NCT07012434
- Acronym / sponsor ID
- SPPH2025381
- Conditions
- Liver Cirrhosis
- Keywords
- Postoperative delirium, gut microbiota dysbiosis, metabolomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 10 Jun 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.
This study looks at memory problems after surgery in people with liver disease. We want to know how often these problems happen and what might cause them. The main question it aims to answer is:
- Do people with liver disease have more memory problems after stomach surgery than people without liver disease? If yes, how much more often?
- Are changes in stomach bacteria and body chemicals related to these memory problems?
Who can join:
- Adults getting stomach surgery
- Both people with and without liver disease
What participants will do:
- Take memory tests before and after surgery
- Give stool (poop) and blood samples before and after surgery
Why this matters:
Memory problems after surgery can make recovery harder. If we find that stomach bacteria or body chemicals are involved, doctors might find new ways to prevent these problems in people with liver disease.
Detailed description
Liver cirrhosis is one of the most prevalent global diseases, ranking as the 11th leading cause of death worldwide with approximately 1 million annual fatalities. China has an estimated 300 million patients with liver diseases, including 7 million cirrhosis cases, accounting for 11% of global cirrhosis-related mortality. Previous studies report that approximately 1 in 10 cirrhosis patients require hepatic or non-hepatic surgical interventions during their final two years of life. With advancements in perioperative techniques including surgery, anesthesia, critical care, and nursing, non-hepatic surgeries for cirrhotic patients have become increasingly common.
The major postoperative complications in cirrhotic patients include coma, hepatic failure, sepsis, hemorrhage, thrombosis, and renal failure, among which coma represents the most frequent complication. These findings highlight the critical scientific importance of reducing postoperative complications in cirrhotic patients, particularly neurological complications.
Postoperative delirium (POD) refers to delirium occurring within one week after surgical procedures, with characteristic temporal features predominantly manifesting 24-72 hours postoperation. POD adversely impacts both short- and long-term patient outcomes. Studies demonstrate that POD patients face 2-3 times higher risk of other postoperative complications, 2-3 times increased perioperative mortality risk and prolonged hospitalization. Long-term follow-up studies reveal that POD patients exhibit increased incidence of postoperative cognitive dysfunction, reduced quality of life and higher long-term mortality rates. Cirrhotic patients frequently present with overt or subclinical cognitive impairment. Surgical intervention in this population may exacerbate neurological dysfunction, potentially explaining the significantly elevated risk of postoperative neurological complications. The commonly observed gut microbiota dysbiosis and metabolic disturbances in cirrhotic patients may play pivotal roles in this process.
This study aims to compare POD incidence and perioperative cognitive function changes between cirrhotic and non-cirrhotic patients undergoing upper abdominal surgery, and investigate the role of gut microbiota dysbiosis and metabolic abnormalities in POD pathogenesis among cirrhotic patients through integrated microbiome-metabolome analysis. The findings may provide valuable insights into the mechanisms and potential therapeutic approaches for cognitive dysfunction in cirrhotic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- 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 10 Jun 2025.
- Individual participant dataSharing planned: Undecided. If the subsequent metabolomics or gut microbiome analyses yield particularly significant findings, these data may initially remain unpublished as they could require further validation through basic animal experiments.
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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 Liver Cirrhosis, 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 10 Jun 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 10 Jun 2025.