Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

468 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-21

Study Completion Date

2028-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?

NCT06749483

Critical Illness Intensive Care Unit Delirium Neurocognitive Deficit +3 more

RECRUITING

Gut Microbiota Analysis in IAI Patients With Sepsis-associated Liver Dysfunction

NCT05628493

Gut Microbiota Intra-abdominal Infections Acute Gastrointestinal Injury +1 more

COMPLETED

Critical Care Excellence in Sepsis and Trauma

NCT01426711

Sepsis Trauma

COMPLETED

Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness

NCT05580367

Mental Health Issue Critical Illness Gut Microbiome

UNKNOWN

Biomarkers and Bowel Sounds in Patients With Acute Gastrointestinal Injury

NCT04769830

Gastrointestinal Injury

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis, Trauma Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Oral swab and saliva, human feces collection and blood sampling

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Blood sampling Oral swab and saliva

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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).

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

1. Adult (\>18 years age) patients undergoing open abdominal vascular surgery
2. Ability to obtain patient informed consent,

1. All adults (age ≥18)
2. Ability to obtain Informed Consent prior to blood collection.

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

1. Patients not expected to survive greater than 48 hours.
2. Prisoners.
3. Pregnancy.
4. Previous bone marrow transplantation.
5. Patients with End Stage Renal Disease.
6. Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers)
7. Burn injury greater than 20% TBSA
8. Severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to intensive care unit.

Trauma TBI subgroup (15 participants)

Cardiac-Surgery operation:

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:

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

1. Current, chronic steroid use
2. Pregnancy
3. Current or recent (within 7 days) use of antibiotics.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes