RECRUITING

Microbiome Dysfunction in Surgical Intensive Care Unit Survivors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-06-21
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05357170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult (\>18 years age) patients undergoing open cardiac surgery
  2. 2. Ability to obtain patient informed consent
  3. 3. was placed on cardiopulmonary bypass at their initial operation at UF Health
  1. 1. Inability to obtain informed consent,
  2. 2. Pregnancy
  3. 3. Evidence of multi-organ failure on presentation
  4. 4. Patients with any pre-existing hematological disease (e.g. hemochromatosis, myelodysplastic syndrome, hematologic cancers
  5. 5. Prisoners
  6. 6. Previous bone marrow transplantation
  7. 7. Burn injury greater than 20% TBSA

Contacts and Locations

Study Contact

Ruth Davis, BSN
CONTACT
352-273-8759
ruth.davis@surgery.ufl.edu
Jennifer Lanz, MSN
CONTACT
352-273-5497
jennifer.lanz@surgery.ufl.edu

Principal Investigator

Philip Efron, MD
PRINCIPAL_INVESTIGATOR
UF COM Department of Surgery

Study Locations (Sites)

UF Health at Shands Hospital
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Philip Efron, MD, PRINCIPAL_INVESTIGATOR, UF COM Department of Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-21
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2022-06-21
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • Sepsis; Trauma; Microbiome

Additional Relevant MeSH Terms

  • Sepsis, Trauma Injury