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

This study is currently recruiting participants.
Verified February 2014 by B. Braun Melsungen AG
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01162928
First received: July 14, 2010
Last updated: February 6, 2014
Last verified: February 2014

July 14, 2010
February 6, 2014
May 2013
November 2014   (final data collection date for primary outcome measure)
change in blood oxygenation (PaO2/FIO2 ratio) [ Time Frame: day 1 to day 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01162928 on ClinicalTrials.gov Archive Site
  • rate of parenteral nutrition associated complications equal or better compared to current practice [ Time Frame: day 1 to day 6 ] [ Designated as safety issue: Yes ]
  • disease related complications [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • 28 day-mortality [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • changes in fatty acid composition of cell membranes [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
rate of PN associated complications equal or better compared to current practice, reduction of disease related complications, improvement of outcomes parameters, changes in FA composition of cell membranes [ Time Frame: day 1 to day 6 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Critical Illness
  • Drug: Nutriflex Omega special + Oxepa
    3-chamber-bag combined with enteral nutrition
  • Drug: Nutriflex Lipid special + Pulmocare
    3-chamber-bag combined with enteral nutrition
  • Experimental: 1
    3-chamber-bag combined with Oxepa
    Intervention: Drug: Nutriflex Omega special + Oxepa
  • Active Comparator: 2
    3-chamber-bag combined with Pulmocare
    Intervention: Drug: Nutriflex Lipid special + Pulmocare
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Clinical Development +49-5661-71-0 studies@bbraun.com
Israel
 
NCT01162928
HC-G-H-0804
No
B. Braun Melsungen AG
B. Braun Melsungen AG
Not Provided
Principal Investigator: Pierre Singer, MD Rabin Medical Center, Beilinson Campus
B. Braun Melsungen AG
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP