Gut Microbiome and ICU Delirium Post Cardiac Surgeries

NCT ID: NCT04056338

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intensive Care Unit Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Delirium

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

No interventions assigned to this group

Non-delirium

Patients without delirium.

No intervention

Intervention Type OTHER

No intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jingfen Jin

Role: STUDY_DIRECTOR

SAHZU

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018001113

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.