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โ† Trials
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Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Recruitingn/aAges 18 Years - 110 YearsAllUniversity of Florida
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In 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

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๐Ÿ“‹ 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 โ‰ฅ18 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 โ‰ฅ18 to 54) require both: a. Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by: 1\. Systolic BP (SBP) โ‰ค 90 mmHg or 2. Mean arterial pressure โ‰ค 65 mmHg or 3. Base deficit (BD) โ‰ฅ5 meq or 4. Lactate โ‰ฅ 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) โ‰ค 90 mmHg or ii. Mean arterial pressure โ‰ค 65 mmHg or iii. Base deficit (BD) โ‰ฅ5 meq or iv. Lactate โ‰ฅ 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 โ‰ฅ18) 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.
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What it tests

  • Human feces collection
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Where

1 site
UF Health at Shands Hospital
Gainesville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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