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Completed

NCT Number: NCT01162928

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rabin Medical Center, Beilinson Campus

Petah Tikva, 49100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutriflex Omega special + Oxepa

Drug

3-chamber-bag combined with enteral nutrition

Nutriflex Lipid special + Pulmocare

Drug

3-chamber-bag combined with enteral nutrition

Primary outcomes

  1. change in blood oxygenation (PaO2/FIO2 ratio)

    Time frame: day 1 to day 6

Secondary outcomes

  1. rate of parenteral nutrition associated complications equal or better compared to current practice

    Time frame: day 1 to day 6

  2. disease related complications

    Time frame: Day 28

  3. 28 day-mortality

    Time frame: Day 28

  4. changes in fatty acid composition of cell membranes

    Time frame: Day 12

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2010
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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