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Gut Microbiome and ICU Delirium Post Cardiac Surgeries

Zhejiang University logo

Zhejiang University

Status

Completed

Conditions

Intensive Care Unit Delirium

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04056338
2018001113

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Delirium
Description:
Patients with delirium as assessed by the bedside nurse using Confusion Assessment Method for the ICU.
Non-delirium
Description:
Patients without delirium.
Treatment:
Other: No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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