Multi-omics Analyses Reveal Microbiota-gut-brain Axis in ICU Patients With Post-cardiac Surgery Delirium

This case-control study is planned to recruit patients who meet the enrollment conditions, receive cardiac surgery (cardiac valve surgery or coronary artery bypass surgery) and cardiopulmonary bypass, and sign the informed consent form in the second ward of adult cardiac surgery, Fuwai Hospital. Use RASS, CAM-ICU scales to evaluate postoperative patients and divide them into delirium and non-delirium groups according to whether they had delirium after surgery. There will be 30 patients in each group. Match the two groups in terms of surgical type, duration of cardiopulmonary bypass, gender and age range (± 3 years). Collect and record the preoperative, intraoperative and postoperative data of the enrolled patients, including cardiopulmonary bypass time, ICU stay time, length of mechanical ventilation, hemodynamics and other data. Fecal and/or blood samples are collected from 60 patients before, immediately after and after operation.

The laboratory test and analysis shall be started after the collection of clinical samples. Fecal samples are used for Metagenomics Sequencing and Functional genomics. Blood samples are analyzed by serum metabolomics for changes in intestinal metabolites entering the blood circulation. Simultaneous measurement of IL-6 and TNF in peripheral blood with serum samples- α, IL-1a,IFN-γ and LPS, D-lactic acid and diamine oxidase levels.Use Multi-omics approach to analyze the correlation between intestinal flora diversity, functional gene abundance and blood metabolites, inflammation level and intestinal barrier function, and to find the clinical evidence of the correlation between microbiota-gut-brain axis and the occurrence of POD in patients. Through comprehensive analysis of the research results of this experiment, access to literature, write papers, submit papers and publish relevant papers.

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Key information

Conditions

Postoperative Delirium Cardiac Disease Cardiovascular Diseases Confusion Delirium Emergence Delirium Gastrointestinal Microbiome Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

elective cardiac valve surgery or coronary artery bypass grafting
open heart surgery under hypothermic cardiopulmonary bypass under intravenous and/or inhalation general anesthesia
No history of delirium attack, no cognitive impairment, normal speech, and certain ability of speaking and reading
age>18
Informed consent of patients, voluntary participation (or consent of family members), and signing of informed consent

Exclusion criteria

There are organic brain diseases (preoperative brain CT examination)
Hearing or visual impairment that may affect delirium assessment
Suspected or confirmed history of alcohol/drug/drug abuse
Previous history of mental illness or preoperative use of antipsychotic drugs
Moderate and severe renal function damage (blood creatinine > 2mg/dL or 177mmol/L) or abnormal liver function (alanine aminotransferase>2 times the upper limit of normal value) or other serious lung diseases
Hematologic diseases, bone marrow and/or lymphoid diseases, leukopenia
Use immunosuppressive drugs or autoimmune diseases
Pregnant
Accompanied by other diseases that may affect their survival, such as tumor
HIV

Treatment and study plan

Primary outcomes

postoperative delirium

Time frame: 1-4 days after cardiac surgery

Use the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) to identify delirium in critically ill patients.The CAM-ICU consists of four main components:inattention, autonomic instability, disorganized thinking, altered level of consciousness.If patient have 1) acute onset of mental status changes or a fluctuating course and 2)inattention and 3)disorganized thinking or 4)altered level of consciousness, thus the patient can be assessed as postoperative delirium (1+2+3/4=POD).
type of postoperative delirium

Time frame: 1-4 days after cardiac surgery

The Richmond Agitation Sedation Scale (RASS) is an instrument designed to assess the level of alertness and agitated behavior in critically-ill patients.The RASS is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, levels +1 to +4 describe increasing levels of agitation,level 0 is "alert and calm." 1.Hyperactive POD: postoperative delirium patient with RASS scores +1~+4; 2.Hypoactive POD:Hyperactive POD: postoperative delirium patient with RASS scores -3~0; 3.Mixed POD: postoperative delirium patient with RASS score fluctuate between positive and negative.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 28, 2022
Registry last updated: Apr 17, 2024

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.

Published trials that share one or more normalized conditions with this study.

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