An observational study in Postoperative Delirium, Cardiac Disease and Gastrointestinal Microbiome, sponsored by China National Center for Cardiovascular Diseases. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by China National Center for Cardiovascular Diseases · Observational
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 418 observational studies indexed under Delirium.
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patients who meet the enrollment conditions, receive cardiac surgery (heart valve surgery or coronary artery bypass surgery) and cardiopulmonary bypass (CPB) in the Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences.
Exclusion Criteria:
According to RASS and CAM-ICU scales, patients who suffer from post-cardiac surgery delirium in ICU will be include into POD group
According to RASS and CAM-ICU scales，patients who do not judge as post-cardiac surgery delirium in ICU will be include into non-POD group
postoperative delirium
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).
Time frame: 1-4 days after cardiac surgery
type of postoperative delirium
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.
Time frame: 1-4 days after cardiac surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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China National Center for Cardiovascular Diseases