Clinical trial NCT01162928: Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients
Official title: Assessment of the Benefit From Combined Administration of Oral and Intravenous Nutrition - Enriched With Omega-3 Fatty Acids - for Intensive Care Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Illness
Keywords: critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: - 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

Primary outcomes:
measure: change in blood oxygenation (PaO2/FIO2 ratio)
timeFrame: day 1 to day 6
Secondary outcomes:
measure: rate of parenteral nutrition associated complications equal or better compared to current practice
timeFrame: day 1 to day 6
measure: disease related complications
timeFrame: Day 28
measure: 28 day-mortality
timeFrame: Day 28
measure: changes in fatty acid composition of cell membranes
timeFrame: Day 12
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Campus
Study officials:
affiliation: Rabin Medical Center, Beilinson Campus
name: Pierre Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singer P, Bendavid I, Mesilati-Stahy R, Green P, Rigler M, Lev S, Schif-Zuck S, Amiram A, Theilla M, Kagan I. Enteral and supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients - A randomized, controlled, double-blind clinical trial. Clin Nutr. 2021 May;40(5):2544-2554. doi: 10.1016/j.clnu.2021.03.034. Epub 2021 Apr 1.