Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients

Study Overview
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Brief Summary
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The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.

Official Title
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Assessment of the Benefit From Combined Administration of Oral and Intravenous Nutrition - Enriched With Omega-3 Fatty Acids - for Intensive Care Patient

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Nutriflex Omega special + Oxepa
* Drug: Nutriflex Lipid special + Pulmocare


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3-chamber-bag combined with Oxepa | Drug: Nutriflex Omega special + Oxepa<br>* 3-chamber-bag combined with enteral nutrition<br>|
| Active Comparator: 2<br>3-chamber-bag combined with Pulmocare | Drug: Nutriflex Lipid special + Pulmocare<br>* 3-chamber-bag combined with enteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood oxygenation (PaO2/FIO2 ratio) |  | day 1 to day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support