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

Active, not recruiting

• Conditions: Critical Illness; Microbiome

• Registration Number: NCT04552834
• Lead Sponsor: University of Chicago

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study Start: 2020-09-15
• Study First Posted: 2020-09-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

adult patients admitted to the intensive care unit

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long Term Mortality	up to 1 year	Death from any cause 90 day, 1 year

Secondary Outcome Measures

Name	Time	Method
Cognitive Dysfunction	Up to 12 months after discharge	Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome
Functional Status Score	up to 12 months after discharge	Katz Index of Independence in activities of daily living; minimal score = 0; maximum score = 6; higher score better outcome
Hospital length of stay	hospitalization up to 6 weeks	number of days admitted to the hospital
hospital mortality	28 day	death from any cause during hospitalization
ICU length of stay	hospitalization up to 6 weeks	number of days admitted to the ICU
Quality of Life score	up to 12 months after discharge	SF-36 score: including physical component summary (PCS) and mental component summary (MCS)

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States