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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJena University Hospital

About this trial

Here, the investigators propose to study host responses to reduced microbiome complexity driven by treatment with broad spectrum antibiotics in patients with severe infections or sepsis. The proposal aims to combine holistic approaches with emerging experimental technologies to investigate the complex interactions between the gut microbiota and its host and assess the impact of specific bacterial communities on longevity and stress responses. A strong focus of this study will also be placed on microbiome dysbiosis and secondary impacts on short- and long-term brain dysfunction using clinical, laboratory and imaging procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

One of the following criteria

Critically ill patients treated with meropenem or piperacillin/tazobactam started within the last 72 h

Critically ill patients without systemic antimicrobial therapy within the last 72 hours and an expected ICU length of stay of more than 3 days

Disqualifiers

Inflammatory bowel disease

Major bowel resection

Selective decontamination of the oral and digestive tract

Oral vancomycin therapy

Trial population

ICU patients with and without antibiotic treatment as well as patients with long-term survival after critical illness

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 3 trial groups
Group A: ICU patients with antibiotic treatment
Group B: ICU patients without antibiotic treatment
Group C: Long-term survivors of critical illness

Trial outcomes

Primary outcomes

1

Number of patients with brain dysfunction

Patients from all three groups will be assessed for microbiome dysbiosis (e.g. shotgun metagenomics), and for brain dysfunction (e.g. CAM-ICU, ICDSC, MoCa, MMST, neuropsychiatric examination, MRI).

Time frame
From enrollment to day 180

Secondary outcomes

1

Number of patients with survival

Time frame
From enrollment to the end of study at 180 days
2

Days on the ICU

Time frame
From enrollment to the end of study at 180 days
3

Days on the respirator

Time frame
From enrollment to the end of study at 180 days
4

Days with vasopressor support

Time frame
From enrollment to the end of study at 180 days

Other outcomes

Sponsors and contacts

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Jena University Hospital

Lead sponsor

University of Jena

Collaborator