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

NCT06749483 | Recruiting

• 1 other identifier: 2024-3429-BO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Intensive Care Unit Delirium; Neurocognitive Deficit; Microbiome,immune Function, Critically Ill; Infection in ICU; Sepsis

Keywords

sepsis; broad-spectrum antibiotics; stool; neuropsychological assessment; delirium; neurocognitive impairment; microbiome

Outcome Measures

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).

  From enrollment to day 180

Secondary Outcomes (4)

• Number of patients with survival

  From enrollment to the end of study at 180 days

• Days on the ICU

  From enrollment to the end of study at 180 days

• Days on the respirator

  From enrollment to the end of study at 180 days

• Days with vasopressor support

  From enrollment to the end of study at 180 days

Study Arms (3)

ICU patients with antibiotic treatment

ICU patients treated with piperacillin/tazobactam or meropenem

ICU patients without antibiotic treatment

ICU patients without antibiotic treatment during their ICU stay

Long-term survivors of critical illness

Long-term survivors at least six months or more after the beginning of critical illness.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Long-term survivors of sepsis, e.g. from pre-existing sepsis cohorts

You may not qualify if:

• Inflammatory bowel disease
• Major bowel resection
• Selective decontamination of the oral and digestive tract
• Oral vancomycin therapy
• Immunocompromised patients
• History of chemotherapy during the last 6 months.
• Known travel history to countries to areas of high antimicrobial resistance (\>5% according to the report of the European Centre for Disease Prevention and Control and all countries except USA and Canada) within the last 4 weeks
• Acute neurological diseases (e.g., brain ischemia, hemorrhage, meningoencephalitis, tumor)
• Manifest dementia, pre-existing psychiatric diseases (schizophrenia, psychosis)
• Acute brain surgery
• MRI contraindications: pacemakers, hearing aids, neurostimulation, insulin pumps, other potentially ferromagnetic implants, screws, clips, prostheses, metal splinters, etc., pregnancy, claustrophobia, extensive tattoos.

Sponsors & Collaborators

• Jena University Hospital: lead
• Friedrich Schiller University of Jena: collaborator

Study Sites (1)

Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool samples as well as rectal swaps.

MeSH Terms

Conditions

Critical Illness; Sepsis; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Johannes Ehler, Priv.-Doz. Dr. med.

  Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+49 36419323397; johannes.ehler@med.uni-jena.de

Katrin Ludewig, Dr. med.

CONTACT

+49 36419323378; katrin.ludewig@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 27, 2024
• Study Start: December 27, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)