Actively Recruiting

Age: 18Years +
All Genders
ID06749483

The Gut Microbiome as a Source of Sepsis and Brain Dysfunction in Intensive Care Units Research on Human Tissue, Body Fluids, Neuropsychological Testing, and Brain Imaging

Led by Jena University Hospital · Updated on 2024-12-30

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

J

Jena University Hospital

Lead Sponsor

U

University of Jena

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how reduced complexity of gut bacteria caused by broad spectrum antibiotic treatment affects patients with severe infections or sepsis, focusing especially on the gut microbiome's role in brain dysfunction. This observational study involves critically ill patients receiving intensive care, examining the complex interactions between gut bacteria and the human body to understand impacts on longevity, stress responses, and brain function. The research aims to link changes in the microbiome to short- and long-term brain problems using clinical evaluations, lab tests, and brain imaging. Participants will provide feces, rectal swabs, and blood plasma samples at five time points: on the first day of ICU admission, day 7, day 14, and during follow-up visits at 3 and 6 months after initial inclusion. The study collects clinical data, neuropsychological tests, and brain imaging results such as functional MRI to assess brain dysfunction. Antibiotic treatment status is recorded, comparing patients treated with broad spectrum antibiotics to those without. Daily delirium screening is conducted during ICU stays using established tests, and cognitive function is assessed at hospital discharge with tools like the Montreal Cognitive Assessment and Mini Mental Status Examination. Researchers also analyze immune cell types through advanced genetic techniques and compare blood cell activation between younger and older patients. The main outcome measured is the number of patients experiencing brain dysfunction over 180 days from enrollment.

CONDITIONS

Official Title

The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years
  • Critically ill patients treated with meropenem or piperacillin/tazobactam started within the last 72 hours
  • Critically ill patients without systemic antimicrobial therapy within the last 72 hours and expected ICU stay longer than 3 days
  • Long-term survivors of sepsis from existing sepsis cohorts
Not Eligible

You will not qualify if you...

  • Inflammatory bowel disease
  • Major bowel resection
  • Use of selective decontamination of the oral and digestive tract
  • Oral vancomycin therapy
  • Immunocompromised status
  • Chemotherapy within the last 6 months
  • Recent travel to high antimicrobial resistance areas (except USA and Canada) within 4 weeks
  • Acute neurological diseases such as brain ischemia, hemorrhage, meningoencephalitis, tumor
  • Manifest dementia or pre-existing psychiatric diseases like schizophrenia or psychosis
  • Recent acute brain surgery
  • MRI contraindications including pacemakers, implants, pregnancy, claustrophobia, or extensive tattoos

AI-Screening

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Trial Site Locations

Total: 1 location

1

Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena

Jena, Thuringia, Germany, 07747

Actively Recruiting

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Research Team

J

Johannes Ehler, Priv.-Doz. Dr. med.

K

Katrin Ludewig, Dr. med.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Correlation of brain injury biomarkers with brain dysfunction, brain injury, and outcomes in critically ill patients: a post hoc exploratory analysis.

M Rühlmann, L Xu, M Bauer...

https://pubmed.ncbi.nlm.nih.gov/41973367