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

This study is currently recruiting participants.
Verified July 2017 by B. Braun Melsungen AG
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162928
First Posted: July 15, 2010
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
B. Braun Melsungen AG
July 14, 2010
July 15, 2010
July 27, 2017
May 2013
November 2017   (Final data collection date for primary outcome measure)
change in blood oxygenation (PaO2/FIO2 ratio) [ Time Frame: day 1 to day 6 ]
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 ]
  • disease related complications [ Time Frame: Day 28 ]
  • 28 day-mortality [ Time Frame: Day 28 ]
  • changes in fatty acid composition of cell membranes [ Time Frame: Day 12 ]
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 ]
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: Quadruple (Participant, Care Provider, 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 2018
November 2017   (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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Clinical Development +49-5661-71-0 studies@bbraun.com
Israel
 
 
NCT01162928
HC-G-H-0804
No
Not Provided
Not Provided
B. Braun Melsungen AG
B. Braun Melsungen AG
Not Provided
Principal Investigator: Pierre Singer, MD Rabin Medical Center, Beilinson Campus
B. Braun Melsungen AG
July 2017

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