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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: t
View:

• 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.

⁃ 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

⁃ 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).

• 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.

Locations
United States
Florida
UF Health at Shands Hospital
RECRUITING
Gainesville
Contact Information
Primary
Ruth Davis, BSN
ruth.davis@surgery.ufl.edu
352-273-8759
Backup
Jennifer Lanz, MSN
jennifer.lanz@surgery.ufl.edu
352-273-5497
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 468
Treatments
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
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.
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
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.
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
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
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: National Institute of General Medical Sciences (NIGMS)

This content was sourced from clinicaltrials.gov