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Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

University of Florida · with National Institute of General Medical Sciences (NIGMS) · NCT05357170

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–110 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
468
US sites recruiting
1
Study start
June 21, 2022
Record last updated
July 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: Human feces collection

Conditions: Sepsis, Trauma Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Sepsis Population

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • Patients with End Stage Renal Disease.
  • Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers)
  • Burn injury greater than 20% TBSA
  • Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit.

Trauma TBI subgroup (15 participants)

Inclusion criteria will be

  • Any adult age 18 or older with any traumatic bleed (intracerebral hemorrhage, subarachnoid hemorrhage, intraparenchymal hemorrhage, subdural hematoma, cerebral epidural hematoma) and any GCS (Glasgow Coma Score).

Exclusion criteria is the same used for the trauma cohort.

Cardiac-Surgery operation

Inclusion Criteria

  • Adult (>18 years age) patients undergoing open cardiac surgery
  • Ability to obtain patient informed consent
  • was placed on cardiopulmonary bypass at their initial operation at UF Health

Exclusion Criteria

  • Inability to obtain informed consent,
  • Pregnancy
  • Evidence of multi-organ failure on presentation
  • Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
  • Prisoners
  • Previous bone marrow transplantation
  • Burn injury greater than 20% TBSA

Open abdominal vascular operation

Inclusion Criteria

  • Adult (>18 years age) patients undergoing open abdominal vascular surgery
  • Ability to obtain patient informed consent,

Exclusion Criteria

  • Inability to obtain informed consent,
  • Pregnancy
  • Evidence of multi-organ failure on presentation
  • Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
  • Prisoners
  • Previous bone marrow transplantation.
  • Burn injury greater than 20% TBSA

Healthy Control

Inclusion criteria will be

  • All adults (age ≥18)
  • Ability to obtain Informed Consent prior to blood collection.

Exclusion Criteria will be

  • Current, chronic steroid use
  • Pregnancy
  • Current or recent (within 7 days) use of antibiotics.

Recruiting US locations

  • UF Health at Shands Hospital

    Gainesville, FL 32610

    Site contact: Ruth Davis, BSN · 352-273-8759 · ruth.davis@surgery.ufl.edu

Study contacts (from the official record)

  • Ruth Davis, BSN · 352-273-8759 · ruth.davis@surgery.ufl.edu
  • Jennifer Lanz, MSN · 352-273-5497 · jennifer.lanz@surgery.ufl.edu
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors (NCT05357170) | Bored Studies