Status:
COMPLETED
Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Critical Illness
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01162928
Start Date
May 1 2013
End Date
November 1 2017
Last Update
April 27 2018
Active Locations (1)
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1
Rabin Medical Center, Beilinson Campus
Petah Tikva, Israel, 49100