UF Health at Shands Hospital
Gainesville, Florida, 32610, United States
Location status: Recruiting
Location contact
Jennifer Lanz, MSN
CONTACT
Philip Efron, MD
PRINCIPAL_INVESTIGATOR
Ruth Davis, BSN
CONTACT
NCT Number: NCT05357170
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
Interested in participating?
Request Info18 year–110 year
All sexes
Observational
Gainesville, Florida, 32610, United States
Location status: Recruiting
Jennifer Lanz, MSN
CONTACT
Philip Efron, MD
PRINCIPAL_INVESTIGATOR
Ruth Davis, BSN
CONTACT
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Sepsis Population
Inclusion criteria
Exclusion criteria
k) Burn injury greater than 20% TBSA (total body surface area)
Trauma Population
Inclusion criteria
a. Blunt and/or penetrating trauma patient with i. Hemorrhagic shock defined by:
b. Injury Severity Score (ISS) greater than or equal to 15
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
Trauma TBI subgroup (15 participants)
Inclusion criteria
will be:
Exclusion criteria
is the same used for the trauma cohort.
Cardiac-Surgery operation:
Inclusion criteria
Exclusion criteria
Open abdominal vascular operation:
Inclusion criteria
Exclusion criteria
Healthy Control
Inclusion criteria
will be:
Exclusion criteria
will be:
Oral swab and saliva, human feces collection and blood sampling
Other names: Blood sampling, Oral swab and saliva
Time frame: through study completion, an average of 6 months
Identify oral and gut microbiome dysfunction through Microbial Taxonomic Analysis and Meta-transcriptomic Analysis
Contact information is provided by the study sponsor or research team.
Jennifer Lanz, MSN
CONTACT
Ruth Davis, BSN
CONTACT
University of Florida
Other
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors Subtitle: The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma Pathological Myeloid Activation After Sepsis and Trauma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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