Status:
RECRUITING
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Sepsis, Trauma Injury
Eligibility:
All Genders
18-110 years
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 sy...
Detailed Description
The investigators hypothesize that alterations of the oral and gut microbiota will correlate with persistent systemic inflammation in surgical intensive care unit survivors compared to existing health...
Eligibility Criteria
Inclusion
- 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
- 1\. All adults (age ≥18 to 54) require both:
- a. Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by:
- 1\. 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
- 2\. 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:
- 1\. 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:
- 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
- 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,
Key Trial Info
Start Date :
June 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT05357170
Start Date
June 21 2022
End Date
May 31 2028
Last Update
June 12 2025
Active Locations (1)
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1
UF Health at Shands Hospital
Gainesville, Florida, United States, 32610