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/41973367Actively Recruiting
Led by Jena University Hospital · Updated on 2024-12-30
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
J
Jena University Hospital
Lead Sponsor
U
University of Jena
Collaborating Sponsor
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
The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?
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Total: 1 location
1
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747
Actively Recruiting
J
Johannes Ehler, Priv.-Doz. Dr. med.
K
Katrin Ludewig, Dr. med.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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M Rühlmann, L Xu, M Bauer...
https://pubmed.ncbi.nlm.nih.gov/41973367