Gut Microbiome and ICU Delirium Post Cardiac Surgeries

Second Affiliated Hospital, School of Medicine, Zhejiang University60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intensive Care Unit Delirium

Interventions

No interventionOTHER

No intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: within 24 hours of delirium

Secondary Outcomes

Gut barrier biomarkers

Blood sample will be collected to analyze the level of three gut barrier biomarkers (endotoxin, D-lactate and diamine oxidase).

Time frame: within 24 hours of matched samples

Data from ClinicalTrials.gov

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