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Recruiting NCT05357170

Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Trial Parameters

Condition Sepsis, Trauma Injury
Sponsor University of Florida
Study Type OBSERVATIONAL
Phase N/A
Enrollment 468
Sex ALL
Min Age 18 Years
Max Age 110 Years
Start Date 2022-06-21
Completion 2027-05-31
Interventions
Human feces collection

Brief Summary

Oral and gastrointestinal microbiome dysfunction has been demonstrated to be a culprit of various systemic dysfunctions in peripheries such as cardiovascular, nervous, endocrine and musculoskeletal systems. The topic of microbiome dysfunction after surgical intensive care admission is understudied but may be responsible for persistent systemic inflammation clinically observed in surgical intensive care patients. Therefore, the objective of this project is to investigate the oral and gut microbiome after the acute phase of sepsis, severe trauma injury, cardiopulmonary bypass, and major vascular surgery to compare with 108 age-matched healthy population controls

Eligibility Criteria

Sepsis Population Inclusion Criteria 1. Admission to the 46, 77, 87, 4 East, 4 West, or 24-5 ICUs where clinical care can be managed by the critical care organization guided by standard operating procedures. 2. Age ≥18 years 3. Meets Sepsis 3 criteria at time of sepsis diagnosis 4. Has remained in ICU for 14 days (+/- 7 days) following sepsis diagnosis. 5. Ability to obtain patient/LAR informed consent. 6. Is receiving adequate nutritional intake: oral or enteral nutrition. Exclusion Criteria 1. Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit 2. Refractory shock (i.e., patients who are expected to die within 12 hours). 3. Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel). 4. Patient or patient's family are not committed to aggressive management of the patient's condition. 5. Known HIV infection with CD4 count \<200 cells/mm3. 6. Organ transplant recipient on immunosuppressiv

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