Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Recruiting

• Conditions: Sepsis, Trauma Injury

• Registration Number: NCT05357170
• Lead Sponsor: University of Florida

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).

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2022-06-21
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2027-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 468

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 ≥18)
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UF Health at Shands Hospital; 🇺🇸 Gainesville, Florida, United States