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OpenTrials
Completed

NCT Number: NCT04056338

Gut Microbiome and ICU Delirium Post Cardiac Surgeries

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.

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Key information

Conditions

Intensive Care Unit Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention.

Primary outcomes

  1. Gut microbiome

    Time frame: within 24 hours of delirium

    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.

Secondary outcomes

  1. Gut barrier biomarkers

    Time frame: within 24 hours of matched samples

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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