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

This study is not yet open for participant recruitment.
Verified January 2012 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: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Critical Illness
 Drug: Lipoplus 20% + Oxepa
Drug: Lipofundin MCT 20% + Pulmocare
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • change in blood oxygenation (PaO2/FIO2 ratio) [ Time Frame: day 1 to day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
intravenous lipid emulsion with fractionated fish oil combined with enteral fish oil Oxepa
 Drug: Lipoplus 20% + Oxepa
lipid emulsion for intravenous parenteral nutrition combined with enteral nutrition
Active Comparator: 2
intravenous lipid emulsion combined with enteral Pulmocare
 Drug: Lipofundin MCT 20% + Pulmocare
lipid emulsion for intravenous parenteral nutrition combined with enteral nutrition

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162928

Contacts
Contact: Clinical Development +49-5661-71-0 studies@bbraun.com

Locations
Israel
Rabin Medical Center, Beilinson Campus Not yet recruiting
Petah-Tikva, Israel, 49100
Contact: Pierre Singer, MD     +97239376521        
Principal Investigator: Pierre Singer, MD            
Sub-Investigator: Haim Shapiro, MD            
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Pierre Singer, MD Rabin Medical Center, Beilinson Campus
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01162928     History of Changes
Obsolete Identifiers: NCT01148589
Other Study ID Numbers: HC-G-H-0804
Study First Received: July 14, 2010
Last Updated: January 9, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on October 17, 2012