Sepsis (according Sepsis-3 definition) R65.1
Conditions
Interventions
Group 1: Enteral nutrition with Fresubin® HP Energy (Fresenius Kabi, Germany)
Group 2: Enteric nutrition with KetoCal® 4: 1 (Nutricia GmbH, Germany)
Sponsors
Universitätsklinikum Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of sepsis < 36h according to sepsis 3-definition / mechanical ventilation < 72h / age = 18 years / written consent or positive vote of an independent consultant
Exclusion criteria
Exclusion criteria: Rejection by patient, legal representative or independent consultant / age 72 h before diagnosis of sepsis / pre-existing long-term ventilation or respiratory home care/ diagnosis of Sepsis >36h / do not resuscitate order / personal relationship to the examiner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ketone body concentration in patients suffering from sepsis within 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and Outcome parameters: 30-day mortality; intensive treatment duration; hospital treatment duration; vasopressor-free days on day 30; dialysis-free days on day 30; ventilation-free days on day 30; Short-Form-36 Health Questionnaire on day 30; SOFA score; SAPS II / TISS; laboratory chemistry parameters( differential blood count, triglyceride and renal function parameters, CRP, IL-6, PCT, blood glucose); CMV/EBV reactivation rate after 7 and 14 days; hypoglycemia (within 14 days; blood glucose concentration < 63mg/dL); metabolic acidosis (within 14 days; reduced pH of <7.3 and reduced serum bicarbonate of < 22 mEq/L); insulin requirement; catecholamine requirement; intolerances with enteral nutrition within 14 days; cholesterol concentration; general liver values; number of combined antibiotic preparations; duration of antibiotic therapy; readmission rate to ICU withing 48 hours after transfer 2. Immunological parameters: mRNA expression profiles in T cells; mRNA expression profiles in whole blood (PAXgene); TruCulture whole blood stimulation (ex vivo), followed by analysis of cytokine; secretion by multiplex assay; Cytomegalovirus/Epstein-Barr virus reactivation rate after 7 days and after 14 days 3. Feasibility parameters: Patients' acceptance / adherence / compliance with the intervention; practicability of the intervention in the intensive care setting; ensuring representative and adequate recruitment and enrolment with respect to the selected inclusion and exclusion criteria; willingness of patients to participate in the study; the willingness of study physicians to enroll patients in the study; assessment of the selected primary endpoint in terms of measurability, quality and statistical power; Follow-up rates, response rates to the SF-36 questionnaire | — |
Countries
Germany
Contacts
Public ContactTim Rahmel
Universitätsklinikum Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerzmedizin
Outcome results
None listed