Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Conditions

• Sepsis, Trauma Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 110 Years

Healthy Volunteers

Accepted

Interventions

• Human feces collection — OTHER
  Oral swab and saliva, human feces collection and blood sampling

Study Details

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

Key Dates

Start date

Jun 21, 2022

Status verified

Jun 2025

Primary completion

May 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

468 participants (estimated)

Arms

• Arm: Sepsis Survivors
  Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection
• Arm: Healthy Control Population
  One time collection of oral swab and saliva, feces, and blood upon enrollment used for comparison to identify microbial genes associated with persistent systemic inflammation in sepsis survivors.
• Arm: Trauma Survivor
  Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection
• Arm: Traumatic Brain Injury (TBI)
  Oral swab, saliva, and feces collected at admission (day 1(+5)) and between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first and second feces collection.
• Arm: Cardiopulmonary Bypass
  Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection
• Arm: Major Vascular Surgery
  Oral swab, saliva, and feces collected between 7 to 28 days of hospital admission and at 3 and 6 months post hospitalization. Telephone call at 12 months. Blood will be collected at time of first feces collection

Primary Outcome Measure

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. [ Time Frame: through study completion, an average of 6 months ]

Central Contacts

• Ruth Davis, BSN
  352-273-8759
  [email protected]
• Jennifer Lanz, MSN
  352-273-5497
  [email protected]

Locations (1)

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