๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Sepsis Population
Inclusion Criteria
1. 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.
2. Age โฅ18 years
3. Meets Sepsis 3 criteria at time of sepsis diagnosis
4. Has remained in ICU for 14 days (+/- 7 days) following sepsis diagnosis.
5. Ability to obtain patient/LAR informed consent.
6. Is receiving adequate nutritional intake: oral or enteral nutrition.
Exclusion Criteria
1. Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit
2. Refractory shock (i.e., patients who are expected to die within 12 hours).
3. Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel).
4. Patient or patient's family are not committed to aggressive management of the patient's condition.
5. Known HIV infection with CD4 count \<200 cells/mm3.
6. Organ transplant recipient on immunosuppressive agents.
7. Known pregnancy.
8. Prisoners.
9. 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 โฅ18 to 54) require both:
a. Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by:
1\. Systolic BP (SBP) โค 90 mmHg or 2. Mean arterial pressure โค 65 mmHg or 3. Base deficit (BD) โฅ5 meq or 4. Lactate โฅ 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) โค 90 mmHg or ii. Mean arterial pressure โค 65 mmHg or iii. Base deficit (BD) โฅ5 meq or iv. Lactate โฅ 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
1. Patients not expected to survive greater than 48 hours.
2. Prisoners.
3. Pregnancy.
4. Previous bone marrow transplantation.
5. Patients with End Stage Renal Disease.
6. Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers)
7. Burn injury greater than 20% TBSA
8. 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:
Inclusion Criteria:
1. Adult (\>18 years age) patients undergoing open cardiac surgery
2. Ability to obtain patient informed consent
3. was placed on cardiopulmonary bypass at their initial operation at UF Health
Exclusion Criteria:
1. Inability to obtain informed consent,
2. Pregnancy
3. Evidence of multi-organ failure on presentation
4. Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
5. Prisoners
6. Previous bone marrow transplantation
7. Burn injury greater than 20% TBSA
Open abdominal vascular operation:
Inclusion Criteria:
1. Adult (\>18 years age) patients undergoing open abdominal vascular surgery
2. Ability to obtain patient informed consent,
Exclusion Criteria:
1. Inability to obtain informed consent,
2. Pregnancy
3. Evidence of multi-organ failure on presentation
4. Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
5. Prisoners
6. Previous bone marrow transplantation.
7. Burn injury greater than 20% TBSA
Healthy Control
Inclusion criteria will be:
1. All adults (age โฅ18)
2. Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria will be:
1. Current, chronic steroid use
2. Pregnancy
3. Current or recent (within 7 days) use of antibiotics.