Critical Illness
Conditions
Keywords
critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support
Brief summary
The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.
Interventions
3-chamber-bag combined with enteral nutrition
3-chamber-bag combined with enteral nutrition
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion: - signed informed consent * mechanically-ventilated adults (age 18-80) admitted to Intensive Care Unit, * enteral nutrition does not meet the nutrition goal (at least 80 % of the resting energy expenditure) within the past 36 hours * APACHE II score above the median value of the intensive care unit (id est \> 20) Exclusion: - do not resuscitate status * cardiogenic pulmonary edema * previous (\< 1 month) or ongoing need for corticosteroids \> 0.1 mg/kg prednisolon- equi-valent or other immune suppressive treatment * serum triglycerides \> 300 mg/dl at screening * alterations of coagulation (platelets \<100.000 mm3), PTT \> 60 sec, INR ≥ 2.5 without therapeutic intervention * pregnancy * participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial * known or suspected drug abuse * general contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency * known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients * autoimmune disease or HIV * uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure) * uncompensated ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study * uncompensated renal insufficiency with serum creatinine \> 1.5 mg/dL (\> 133 µmol/L) * patients with severe liver dysfunction with bilirubin \> 2.5 mg/dL (\> 43 µmol/L) * necrotizing pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in blood oxygenation (PaO2/FIO2 ratio) | day 1 to day 6 |
Secondary
| Measure | Time frame |
|---|---|
| rate of parenteral nutrition associated complications equal or better compared to current practice | day 1 to day 6 |
| disease related complications | Day 28 |
| 28 day-mortality | Day 28 |
| changes in fatty acid composition of cell membranes | Day 12 |
Countries
Israel