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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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: Nutriflex Omega special + Oxepa
Drug: Nutriflex Lipid special + 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: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: February 6, 2014
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 September 18, 2014