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RecruitingNCT05357170

Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Microbiome Dysfunction in Surgical Intensive Care Unit Survivors Subtitle: The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma Pathological Myeloid Activation After Sepsis and Trauma

Sponsor

University of Florida

Enrollment

468 participants

Start Date

Jun 21, 2022

Study Type

OBSERVATIONAL

Conditions

Sepsis, Trauma Injury

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

Min Age: 18 YearsMax Age: 110 Years

Inclusion Criteria23

  • Sepsis Population
  • 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.
  • \. 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
  • \. 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).
  • 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
  • Adult (>18 years age) patients undergoing open abdominal vascular surgery
  • Ability to obtain patient informed consent,
  • All adults (age ≥18)
  • Ability to obtain Informed Consent prior to blood collection.

Exclusion Criteria40

  • 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
  • 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)
  • Cardiac-Surgery operation:
  • 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:
  • 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
  • Current, chronic steroid use
  • Pregnancy
  • Current or recent (within 7 days) use of antibiotics.

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Interventions

OTHERHuman feces collection

Oral swab and saliva, human feces collection and blood sampling

Locations(1)

UF Health at Shands Hospital

Gainesville, Florida, United States

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NCT05357170