Clincosm LogoSign in Get a demo

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

Sponsor
University of Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04552834
Collaborator
(none)
500
Enrollment
1
Location
25.5
Anticipated Duration (Months)
19.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes
    Actual Study Start Date :
    Sep 15, 2020
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Long Term Mortality [up to 1 year]

      Death from any cause 90 day, 1 year

    Secondary Outcome Measures

    1. hospital mortality [28 day]

      death from any cause during hospitalization

    2. ICU length of stay [hospitalization up to 6 weeks]

      number of days admitted to the ICU

    3. Hospital length of stay [hospitalization up to 6 weeks]

      number of days admitted to the hospital

    4. 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

    5. Cognitive Dysfunction [Up to 12 months after discharge]

      Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome

    6. Quality of Life score [up to 12 months after discharge]

      SF-36 score: including physical component summary (PCS) and mental component summary (MCS)

    Other Outcome Measures

    1. ICU re-admission [up to 12 months]

      number of admissions to ICU

    2. ICU related complications [up to 6 weeks]

      presence of ICU complications: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness

    3. Ventilator days [up to 4 weeks]

      duration of mechanical ventilation via endotracheal tube

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    adult patients admitted to the intensive care unit

    Exclusion Criteria: none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Medical Center Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    • Principal Investigator: Bhakti Patel, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT04552834
    Other Study ID Numbers:
    • 20-1102
    First Posted:
    Sep 17, 2020
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Chicago
    short term outcomes
    long term outcomes
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of May 25, 2022