Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

Critical Illness Clinical Trial

Official title:

Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04552834
• Other study ID #: 20-1102
• Status: Active, not recruiting
• Start date: September 15, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.

Description:

During this study investigators will longitudinally collect discarded stool biosamples throughout the MICU admission when available. Stool Bio specimens will be recorded/coded and processed by the investigators. Stool Bio specimens will be analyzed for 16sRNA and metabolomics. Surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge.

By longitudinally sampling discarded biospecimens from subjects throughout their MICU admission in additionally to describing long term following up. We will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

adult patients admitted to the intensive care unit

Exclusion Criteria: none

Related Conditions & MeSH terms

• Critical Illness
• Microbiome

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU re-admission	number of admissions to ICU	up to 12 months
Other	ICU related complications	presence of ICU complications: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness	up to 6 weeks
Other	Ventilator days	duration of mechanical ventilation via endotracheal tube	up to 4 weeks
Primary	Long Term Mortality	Death from any cause 90 day, 1 year	up to 1 year
Secondary	hospital mortality	death from any cause during hospitalization	28 day
Secondary	ICU length of stay	number of days admitted to the ICU	hospitalization up to 6 weeks
Secondary	Hospital length of stay	number of days admitted to the hospital	hospitalization up to 6 weeks
Secondary	Functional Status Score	Katz Index of Independence in activities of daily living; minimal score = 0; maximum score = 6; higher score better outcome	up to 12 months after discharge
Secondary	Cognitive Dysfunction	Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome	Up to 12 months after discharge
Secondary	Quality of Life score	SF-36 score: including physical component summary (PCS) and mental component summary (MCS)	up to 12 months after discharge