Sepsis Infections and Infestations Sepsis
Conditions
Interventions
Intestamin® versus placebo
Sponsors
Fresenius Kabi Deutschland GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major entry criteria (suspected or proven infection, presence of a systemic response to the infection within the 48-hour period immediately preceding enrolment into the study, have or have had one or more sepsis-induced organ failures within the 48-hour period immediately preceding enrolment into the study). 1. Age =18 years 2. Acute Physiology and Chronic Health Evaluation II (APACHE II) score =10 3. Precipitating injury (surgery, trauma, hypovolemia, episode of infection or sepsis) occurred within the last 48 hours before intensive care unit (ICU) entry 4. Expected length of stay (LOS) in the ICU >3 days 5. Indication for enteral nutrition for 5-10 days 6. Start of nutritional therapy with Intestamin or control supplement within 24 hours after inclusion criteria are fulfilled
Exclusion criteria
Exclusion criteria: 1. Age 130 kg (estimated) 3. Pregnant and lactating women, women of child-bearing age. Pregnancy in women of child-bearing age should be ruled out with a pregnancy test. 4. Gastrointestinal obstructions, high output enterocutaneous fistulae 5. Severe diarrhoea unresponsive to codeine or loperamide 6. Biopsy proven cirrhosis and documented portal hypertension; episodes of past upper gastrointestinal bleeding attributed to portal hypertension; prior episodes of hepatic failure, encephalopathy or coma 7. Human immunodeficiency virus (HIV)-positive patients with an aquired immune deficiency syndrome (AIDS)-defining process, such as Pneumocystis carnii pneumonia, Kaposi?s sarcoma, progressive multifocal leukoncephalopathy (PML), Mycobacterium avium disease, Epstein-Barr virus (EBV) infection, or lymphoma, or a known CD4 count <200 cells/µl 8. Simultaneous participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Organ dysfunction assessed by daily total SOFA score and by the delta daily total SOFA score (significant reduction). Variables for organ dysfunction (worst parameter per day): 1. Pulmonary: pO2/FiO2 2. Cardiovascular: hypotension 3. Renal: creatinine 4. Hepatic: bilirubin 5. Coagulation: thrombocytes 6. Central nervous system (CNS): Glasgow coma score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality (28-day, ICU and hospital, six-months) 2. Infectious complications (e.g. pneumonia, wound infection, abscesses) 3. APACHE II 4. Organ failure-free days 5. LOS in ICU 6. LOS in hospital (intervention until discharge) 7. Duration of antibiotic treatment (antibiotics days) 8. Duration of ventilation (ventilator days) 9. Duration of renal support | — |
Countries
United Kingdom
Outcome results
None listed