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NCT04056338 Clinical Trial

Gut Microbiome and ICU Delirium Post Cardiac Surgeries

Intensive Care Unit Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04056338
Other study ID # 2018001113
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2019

Study information
Verified date January 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention.

Locations
Country Name City State
China Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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