Gut Microbiome and ICU Delirium Post Cardiac Surgeries

Study Overview
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Brief Summary
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ICU delirium are assessed by clinical nurses twice every day. Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.

Detailed Description
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ICU delirium are assessed by clinical nurses twice every day using Confusion Assessment Method for the ICU (CAM-ICU). Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected within 24 hours after surgeries. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.

Official Title
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Gut Microbiome and Gut Barrier Function in ICU Delirium Post Cardiac Surgery

Conditions
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Intensive Care Unit Delirium

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: to have had heart valve surgery or coronary artery bypass grafting (CABG) to have no planned transfer to another ward or hospital within 24 hours after surgery to have no preoperative cognitive impairment and can speak and read Chinese more than 18 years old Exclusion Criteria: to have a hearing or visual impairment that could impact delirium assessment to have a history of alcohol or drug abuse to have a preoperative intestinal irritation syndrome or history of gastrointestinal disease to have received antibiotics or probiotics within 28 days before admission to have a life expectancy less than 24 hours to have an experience of ICU hospitalization, mechanical ventilation in the past 30 days to have a cardiac surgery or hypoxic brain injury in the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delirium<br>Patients with delirium as assessed by the bedside nurse using Confusion Assessment Method for the ICU. | |
| Non-delirium<br>Patients without delirium. | Other: No intervention<br>* No intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome | Rectal swabs or stool samples for bacterical DNA extraction and 16S rRNA gene sequencing will be collected. Diversity and composition of gut microbiome will be compared between delirious and non-delirious patients. | within 24 hours of delirium | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut barrier biomarkers | Blood sample will be collected to analyze the level of three gut barrier biomarkers (endotoxin, D-lactate and diamine oxidase). | within 24 hours of matched samples | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium