Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

NCT05357170 | Recruiting

• 2 other identifiers: IRB202102863R35GM140806
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

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

Conditions

Sepsis, Trauma Injury

Keywords

Sepsis; Trauma; Microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

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

Other: Human 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.

Other: Human feces collection

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

Other: Human 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.

Other: Human 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

Other: Human 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

Other: Human feces collection

Interventions

Human feces collection OTHER

Oral swab and saliva, human feces collection and blood sampling

Also known as: Blood sampling, Oral swab and saliva

Cardiopulmonary Bypass; Healthy Control Population; Major Vascular Surgery; Sepsis Survivors; Trauma Survivor; Traumatic Brain Injury (TBI)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit
• Refractory shock (i.e., patients who are expected to die within 12 hours).
• Uncontrollable source of sepsis (e.g. irreversible disease state such as unresectable dead bowel).
• Patient or patient's family are not committed to aggressive management of the patient's condition.
• Known HIV infection with CD4 count \<200 cells/mm3.
• Organ transplant recipient on immunosuppressive agents.
• Known pregnancy.
• Prisoners.
• Institutionalized patients j Inability to obtain informed consent.
• k) Burn injury greater than 20% TBSA (total body surface area)
• Trauma Population
• \. All adults (age ≥18 to 54) require both:
• a. Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by:
• \. 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

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): collaborator
• University of Florida: lead

Study Sites (1)

UF Health at Shands Hospital

Gainesville, Florida, 32610, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human oral sample, feces, and blood

MeSH Terms

Conditions

Sepsis; Accidental Injuries; Wounds and Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philip Efron, MD

  UF COM Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Davis, BSN

CONTACT

352-273-8759; ruth.davis@surgery.ufl.edu

Jennifer Lanz, MSN

CONTACT

352-273-5497; jennifer.lanz@surgery.ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 2, 2022
• Study Start: June 21, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

US (1)