Gut Microbiome and ICU Delirium Post Cardiac Surgeries

NCT04056338 | Completed

• 1 other identifier: 2018001113
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Delirium

Keywords

delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gut barrier biomarkers

  within 24 hours of matched samples

Study Arms (2)

Delirium

Patients with delirium as assessed by the bedside nurse using Confusion Assessment Method for the ICU.

Non-delirium

Patients without delirium.

Other: No intervention

Interventions

No intervention OTHER

No intervention.

Non-delirium

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after cardiac surgery and admitted to CSICU are recruited.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jingfen Jin

  SAHZU

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 14, 2019
• Study Start: January 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)