Actively Recruiting
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
Led by University of Florida · Updated on 2025-06-12
468
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admission to designated ICUs with clinical care managed by critical care protocols
- Meet Sepsis 3 criteria at time of sepsis diagnosis (sepsis population)
- Remained in ICU for 14 days (+/- 7 days) after sepsis diagnosis
- Receiving adequate nutrition orally or enterally
- Blunt and/or penetrating trauma with hemorrhagic shock or Injury Severity Score 15 (trauma population)
- Adult patients undergoing open cardiac or abdominal vascular surgery
- Ability to provide informed consent
- Healthy adults age 18 or older able to provide informed consent (healthy controls)
You will not qualify if you...
- Severe traumatic brain injury with Glasgow Coma Score of 3 on ICU admission
- Refractory shock with expected death within 12 hours
- Uncontrollable source of sepsis such as unresectable dead bowel
- Lack of commitment to aggressive management by patient or family
- Known HIV infection with CD4 count less than 200 cells/mm3
- Organ transplant recipients on immunosuppressants
- Pregnancy
- Prisoners or institutionalized patients
- Inability to obtain informed consent
- Burn injury greater than 20% total body surface area
- Previous bone marrow transplantation
- End stage renal disease
- Pre-existing hematological diseases such as hemochromatosis, myelodysplastic syndrome, or hematologic cancers
- Current or recent use of antibiotics or chronic steroid use in healthy controls
- Evidence of multi-organ failure on presentation for surgical patients
AI-Screening
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Trial Site Locations
Total: 1 location
1
UF Health at Shands Hospital
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
R
Ruth Davis, BSN
CONTACT
J
Jennifer Lanz, MSN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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