I25.1 R65.2 F05.8 T81.1 R57.2 J95.1 K56.7 R65.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Scheduled surgery using the use of cardio-pulmonary Bypass; male and female patients (age> 18 years); written informed consent of the patient.
Exclusion criteria
Exclusion criteria: Patients receiving antibiotic therapy; anal Stenosis; Perianal Bleeding or infections; Emergency indication for surgery; Endocarditis; Immunosuppression or therapy with glucocorticoids above the Cushing threshold (> 7.5 mg prednisolone equivalent); Existing chronic inflammatory bowel disease; Non-consenting Patient; Child Pugh Class C; Women during pregnancy and lactation; Participation in a clinical trial (intervention study) within the last 30 days; Current participation in another clinical trial (intervention study); Participation of the patient in this study earlier; Therapy restriction or setting (e.g., DNR order)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the microbiome analysis is the quantitative change in the diversity of the four dominant bacterial phyla Firmicutes, Bacteroidetes, Proteobacteria and Actinobacteria between baseline and the other investigation times. An exploratory analysis will identify microorganisms that may be drivers, protectors or biomarkers of metabolic disorders associated with poor postoperative outcome or altered metabolic processes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the determination of typical metabolic metabolites from patients' blood samples using mass spectrometry-based technologies and the correlation of metabolite concentration changes with clinical outcome parameters. | — |
Countries
Germany
Contacts
Klinik für Anästhesiologie und Operative Intensivmedizin; Universitätsklinikum Schleswig-Holstein Campus Kiel