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Gut Microbiome and ICU Delirium Post Cardiac Surgeries

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04056338
Enrollment
60
Registered
2019-08-14
Start date
2019-01-01
Completion date
2019-12-30
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Delirium

Keywords

delirium

Brief 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.

Detailed 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.

Interventions

OTHERNo intervention

No intervention.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiomewithin 24 hours of deliriumRectal 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.

Secondary

MeasureTime frameDescription
Gut barrier biomarkerswithin 24 hours of matched samplesBlood sample will be collected to analyze the level of three gut barrier biomarkers (endotoxin, D-lactate and diamine oxidase).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026