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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01162928
Enrollment
100
Registered
2010-07-15
Start date
2013-05-31
Completion date
2017-11-30
Last updated
2018-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

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

DRUGNutriflex Omega special + Oxepa

3-chamber-bag combined with enteral nutrition

DRUGNutriflex Lipid special + Pulmocare

3-chamber-bag combined with enteral nutrition

Sponsors

B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frame
change in blood oxygenation (PaO2/FIO2 ratio)day 1 to day 6

Secondary

MeasureTime frame
rate of parenteral nutrition associated complications equal or better compared to current practiceday 1 to day 6
disease related complicationsDay 28
28 day-mortalityDay 28
changes in fatty acid composition of cell membranesDay 12

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026