Sepsis, Trauma Injury
Conditions
Keywords
Sepsis; Trauma; Microbiome
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 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
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 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).
Interventions
OTHERHuman feces collection
Oral swab and saliva, human feces collection and blood sampling
Sponsors
University of Florida
National Institute of General Medical Sciences (NIGMS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
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 ≥18 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 ≥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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | through study completion, an average of 6 months | Identify oral and gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis |
Countries
United States
Contacts
CONTACTRuth Davis, BSN
CONTACTJennifer Lanz, MSN
PRINCIPAL_INVESTIGATORPhilip Efron, MD
UF COM Department of Surgery
Outcome results
None listed