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

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ClinicalTrials.gov Identifier: NCT01162928
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

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.

Condition or disease Intervention/treatment Phase
Critical Illness Drug: Nutriflex Omega special + Oxepa Drug: Nutriflex Lipid special + Pulmocare Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: 1
3-chamber-bag combined with Oxepa
Drug: Nutriflex Omega special + Oxepa
3-chamber-bag combined with enteral nutrition

Active Comparator: 2
3-chamber-bag combined with Pulmocare
Drug: Nutriflex Lipid special + Pulmocare
3-chamber-bag combined with enteral nutrition




Primary Outcome Measures :
  1. change in blood oxygenation (PaO2/FIO2 ratio) [ Time Frame: day 1 to day 6 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162928


Locations
Israel
Rabin Medical Center, Beilinson Campus
Petah-Tikva, Israel, 49100
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Pierre Singer, MD Rabin Medical Center, Beilinson Campus

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01162928     History of Changes
Obsolete Identifiers: NCT01148589
Other Study ID Numbers: HC-G-H-0804
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by B. Braun Melsungen AG:
critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes