Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Recruiting now

Conditions studied: Sepsis, Trauma Injury

In brief

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

Key facts

Study ID

NCT05357170

Run by

University of Florida

People needed

468

Starts

2022-06-21

Expected to finish

2028-05-31

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Age ≥18 years
• Meets Sepsis 3 criteria at time of sepsis diagnosis
• Has remained in ICU for 14 days (+/- 7 days) following sepsis diagnosis.
• Ability to obtain patient/LAR informed consent.
• Is receiving adequate nutritional intake: oral or enteral nutrition.

You may not qualify if…

• Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit
• Refractory shock (i.e., patients who are expected to die within 12 hours).
• Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel).
• Patient or patient's family are not committed to aggressive management of the patient's condition.
• Known HIV infection with CD4 count <200 cells/mm3.
• Organ transplant recipient on immunosuppressive agents.
• Known pregnancy.
• Prisoners.
• Institutionalized patients j Inability to obtain informed consent.
• k) Burn injury greater than 20% TBSA (total body surface area)
• Trauma Population
• Inclusion Criteria
• All adults (age ≥18 to 54) require both:
• a. Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by:
• Systolic BP (SBP) ≤ 90 mmHg or 2. Mean arterial pressure ≤ 65 mmHg or 3. Base deficit (BD) ≥5 meq or 4. Lactate ≥ 2 or 5. Active red blood cell or whole blood transfusion within 6 hours of arrival
• b. Injury Severity Score (ISS) greater than or equal to 15
• All adults (age 55 and older) require:
• a. Either hemorrhagic shock defined by: i. Systolic BP (SBP) ≤ 90 mmHg or ii. Mean arterial pressure ≤ 65 mmHg or iii. Base deficit (BD) ≥5 meq or iv. Lactate ≥ 2 or v. Active red blood cell or whole blood transfusion within 6 hours of arrival
• OR
• b. Injury Severity Score (ISS) greater than or equal to 15. 3. Ability to obtain Informed Consent
• Exclusion Criteria
• Patients not expected to survive greater than 48 hours.
• Prisoners.
• Pregnancy.
• Previous bone marrow transplantation.

Where it is running

• UF Health at Shands Hospital — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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