Gut bacteria may drive Long-Term inflammation after sepsis or major trauma
NCT ID NCT05357170
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study investigates how the community of bacteria in the mouth and gut changes after sepsis or severe trauma in people who have been in the intensive care unit. Researchers will compare these patients to healthy individuals to see if microbiome disruption is linked to ongoing inflammation. The goal is to better understand why some ICU survivors experience persistent health problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could point toward new ways to reduce chronic inflammation in ICU survivors by targeting the microbiome.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The findings may not lead to treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 468 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 110 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Exclusion Criteria 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) Inclusion criteria will be: 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). Exclusion criteria is the same used for the trauma cohort. Cardiac-Surgery operation: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UF Health at Shands Hospital
RECRUITINGGainesville, Florida, 32610, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Persistent inflammation, immunosuppression and catabolism syndrome (PICS): a new horizon for surgical critical care subtitle: cardiac dysfunction in older sepsis survivors subtitle: development of a designer Proline-Rich antimicrobial peptide chaperone protein inhibitor (DPC) for treating sepsis
- A randomized clinical trial of early empiric Anti-Mycobacterium tuberculosis therapy for sepsis in Sub-Saharan africa
- Tracing of real-time glu13Cose metabolism in human immune cells - intensive care unit
- Could a neck vein check replace a harder ultrasound for ICU fluid management?
- Machine learning may forecast brain decline after head injury
- Sepsis alert system aims to speed up critical care response in hospitals