Is NCT05357170 recruiting in Gainesville, FL?

Yes, NCT05357170 is currently recruiting participants at its Gainesville, FL location. This sepsis, trauma injury clinical trial is actively enrolling qualified participants.

How do I join the sepsis, trauma injury clinical trial in Gainesville?

To join this clinical trial in Gainesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Gainesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Sepsis, Trauma Injury Clinical Trial in Gainesville, FL

About This Sepsis, Trauma Injury Study in Gainesville

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

Sponsor: University of Florida

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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.

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

Patients not expected to survive greater than 48 hours.

Previous bone marrow transplantation.

Patients with End Stage Renal Disease.

Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers)

Burn injury greater than 20% TBSA

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:

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 Exclusion Criteria:

Inability to obtain informed consent,

Evidence of multi-organ failure on presentation

Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers

Previous bone marrow transplantation

Burn injury greater than 20% TBSA Open abdominal vascular operation: Inclusion Criteria:

Adult (\>18 years age) patients undergoing open abdominal vascular surgery

Ability to obtain patient informed consent, Exclusion Criteria:

Inability to obtain informed consent,

Evidence of multi-organ failure on presentation

Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers

Previous bone marrow transplantation.

Burn injury greater than 20% TBSA Healthy Control Inclusion criteria will be:

All adults (age ≥18)

Ability to obtain Informed Consent prior to blood collection. Exclusion Criteria will be:

Current, chronic steroid use

Current or recent (within 7 days) use of antibiotics.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gainesville?

Yes, this clinical trial (NCT05357170) has an active research site in Gainesville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Sepsis, Trauma Injury Treatment Options in Gainesville, FL

If you're searching for sepsis, trauma injury treatment options in Gainesville, FL, this clinical trial (NCT05357170) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gainesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced sepsis, trauma injury specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all sepsis, trauma injury clinical trials near you to find additional studies recruiting in your area.

Sepsis, Trauma Injury Clinical Trial in Gainesville, FL

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