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| ID | Type | Description | Link |
|---|---|---|---|
| R35GM140806 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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
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 healthy population controls. This research group will collect oral and stool samples from 108 sepsis survivors, 108 trauma survivors, 108 cardiopulmonary bypass survivors, and major vascular surgery survivors (groups of ages 18-45, 46-64, and >65; male and female; n=18 per age + sex cohort) admitted to the surgical intensive care unit between day 7 and 28 of hospital admission, as well as 3 and 6 months after their intensive care unit hospitalization. The investigators will perform 16S rRNA DNA sequencing on the isolated bacterial DNA from these samples and bioinformatic analysis to determine microbiota alterations between time points and between surgical ICU survivor cohorts and a control cohort. In addition, the investigators will draw 20ml of blood to isolate plasma.
Trauma Subgroup for traumatic brain injury (TBI) pilot study: Our team will enroll 15 additional trauma injury patients with traumatic brain injury. This subgroup will have an added stool (if available) and blood sample collection after initial injury (+ 5 days). The additional sample will be compared to the sample collected at 14-21 days and follow up samples at 3 and 6 months. The results will be associated with Glasgow Outcome Scale Extended at 3 and 12 month time points and the recorded discharge Rancho Los Amigos scale score from the medical record. The specific aims will be: Aim 1 - define the impact of persistent systemic inflammation on the gastrointestinal microbiota in sepsis and trauma survivors and Aim 2 - identify microbial genes associated with persistent systemic inflammation in sepsis and trauma survivors compared to normal controls. Trauma Subgroup Aim: Pilot study to test the hypothesis that changes in the microbiome towards pathogenic microbe is associated with worsened outcomes in trauma injury patients with TBI (traumatic brain injury).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepsis Survivors | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
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| Healthy Control Population | One time collection of oral swab and saliva, feces, and blood upon enrollment used for comparison to identify microbial genes associated with persistent systemic inflammation in sepsis survivors. |
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| Trauma Survivor | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
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| Traumatic Brain Injury (TBI) | Oral swab, saliva, and feces collected at admission (day 1(+5)) and between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first and second feces collection. |
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| Cardiopulmonary Bypass | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human feces collection | Other | Oral swab and saliva, human feces collection and blood sampling |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the impact of persistent systemic inflammation on oral and gastrointestinal microbiota in surgical ICU survivors & identify microbial genes associated with persistent systemic inflammation of surgical ICU survivors compared to normal controls. | Identify oral and gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis | through study completion, an average of 6 months |
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Sepsis Population
Inclusion Criteria
Exclusion Criteria
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
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:
Exclusion Criteria:
Open abdominal vascular operation:
Inclusion Criteria:
Exclusion Criteria:
Healthy Control
Inclusion criteria will be:
Exclusion Criteria will be:
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Patients admitted to surgical intensive care units who screen positive for sepsis, have severe trauma injury, undergo cardiopulmonary bypass or major vascular surger and are being treated by our standard-of care ICU protocols are candidates for the study. Healthy adult volunteers will provide reference control samples.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Davis, BSN | Contact | 352-273-8759 | ruth.davis@surgery.ufl.edu | |
| Jennifer Lanz, MSN | Contact | 352-273-5497 | jennifer.lanz@surgery.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Philip Efron, MD | UF COM Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at Shands Hospital | Recruiting | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D000081084 | Accidental Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Human oral sample, feces, and blood
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| Major Vascular Surgery | Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |