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

Tracking Information

First Received Date ^ICMJE

July 14, 2010

Last Updated Date

January 9, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01162928 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Assessment of the Benefit From Combined Administration of Oral and Intravenous Nutrition - Enriched With Omega-3 Fatty Acids - for Intensive Care Patient

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Critical Illness

Intervention ^ICMJE

Drug: Lipoplus 20% + Oxepa
lipid emulsion for intravenous parenteral nutrition combined with enteral nutrition
Drug: Lipofundin MCT 20% + Pulmocare
lipid emulsion for intravenous parenteral nutrition combined with enteral nutrition

Study Arm (s)

Experimental: 1
intravenous lipid emulsion with fractionated fish oil combined with enteral fish oil Oxepa

Intervention: Drug: Lipoplus 20% + Oxepa
Active Comparator: 2
intravenous lipid emulsion combined with enteral Pulmocare

Intervention: Drug: Lipofundin MCT 20% + Pulmocare

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Clinical Development

+49-5661-71-0

studies@bbraun.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01162928

Other Study ID Numbers ^ICMJE

HC-G-H-0804

Has Data Monitoring Committee

Not Provided

Responsible Party

B. Braun Melsungen AG

Study Sponsor ^ICMJE

B. Braun Melsungen AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pierre Singer, MD

Rabin Medical Center, Beilinson Campus

Information Provided By

B. Braun Melsungen AG

Verification Date

January 2012

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

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