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Clinical Trials/NCT04552834
NCT04552834
Active, not recruiting
Not Applicable

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

University of Chicago1 site in 1 country500 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
University of Chicago
Enrollment
500
Locations
1
Primary Endpoint
Long Term Mortality
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
June 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • adult patients admitted to the intensive care unit

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Long Term Mortality

Time Frame: up to 1 year

Death from any cause 90 day, 1 year

Secondary Outcomes

  • Cognitive Dysfunction(Up to 12 months after discharge)
  • Functional Status Score(up to 12 months after discharge)
  • Hospital length of stay(hospitalization up to 6 weeks)
  • hospital mortality(28 day)
  • ICU length of stay(hospitalization up to 6 weeks)
  • Quality of Life score(up to 12 months after discharge)

Study Sites (1)

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