The aim of the presented surveillance is to confirm the results of the pilot study showing a significant reduction in respirator days and ICU-stay in patients with lipid based nutrition compared to standard regimen. Additionally parameters of immunological, inflammatory and illness status between patients with lipid based nutrition and patient with standard regime will be acquired and compared.
Conditions
Interventions
Trade Name: Amino Acids 15%, Glucose 30%, Lipids 55% (parenteral nutrition, Group A)
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: 15 % Amino Acids, 55 % Lipids, 30 % Glucose
Trade
Sponsors
FORIM GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: >18 and = 70 years Indication to receive artificial ventilation for at least 10 days. Oral or enteral nutrition is expected to deliver not more than 30 % of the total Energy needs on day 5 after inclusion. Patient able and willing to sign assumed consent; if patient is not able, the egally authorized representative has to sign a written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or lactating females. Any concomitant illness or abnormal laboratory test which, in the investigator's opinion, would render the patient unsuitable for enrolment. Current therapy that excludes the use of study treatment. Diabetes Type I and II Long term sedation with Propofol. Known alcohol or drug abuse. Known hypersensitivity to the product or excipients. Participation in another clinical drug study. Patients treated with corticoids, cytotoxic drugs, cancer, HIV Age 70 Patients with a gcs score at the scene of accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examination of the effect of lipid based nutrition vs. standard regimen on duration of ventilation in ventilated patients. The aim of the presented surveillance is to confirm the results of the pilot study showing a significant reduction in respirator days (- 6.6 d) and ICU-stay (- 5.6 d) in patients with lipid based nutrition compared to standard regimen. Assuming that this can be shown in a prospective surveillance including a specific number of patients the treatment and outcome of critically ill patients is optimized significantly. ;Secondary Objective: - APACHE II - SAPS-2 - CPIS - markers of inflammation - Immunology - Fatty acid composition of leukocytes, leukotrienes in plasma - LPS-binding protein (LBP) - wound infection - pneumonia - bloodstream infection and days with antibiotics - days with fever - sedation (type and dosis) - inotropic or vasopressor support (type and dosis) - need for transfusion and number of blood products - Insulin requirement - days of intensive care and hospital stay - rehabilitation Barthel-Index at hospital discharge - Mortality in hospital Biological safety parameters - Vital signs - lipid profile - blood glucose - leukocytes, thrombocytes, hemoglobin (Hb), hematocrit (Hk), Quick’s value, albumin, CRP, urea, creatinine, electrolytes, bilirubin - acid-base-status (pH, HCO3) ;Primary end point(s): Respirator days and ICU stay in patients with liped based nutrition compared to standard regimen. Parameters of immunological, inflammatory and illness status between patients with lipid based nutrition and patient with standard regime will be acquired and compared: - Standard parameters of ventilation (pO2, pCO2, FIO2, PEEP, flow, minute volume (ml/kg), pressure (peak pressure and mean pressure) and frequency of ventilation). - days of intensive care and hospital stay. | — |
Countries
Germany
Outcome results
None listed