Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Study Description

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Brief Summary:

The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.

Condition or disease	Intervention/treatment	Phase
Parenteral Nutrition	Drug: SMOF lipid and Intralipid	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	75 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Study Start Date :	October 2007
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; SMOFlipid	Drug: SMOF lipid and Intralipid; 1-2 g, 5-7 days, 28 days
Active Comparator: 2; Intralipid	Drug: SMOF lipid and Intralipid; 1-2 g, 5-7 days, 28 days

Outcome Measures

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Primary Outcome Measures :

1. Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables [ Time Frame: day 0, week 2, week 4 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
• Written consent from the subject

Exclusion Criteria:

• Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
• Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
• Severe liver insufficiency
• Severe blood coagulation disorders
• Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration
• Unstable conditions
• Unstable angina pectoris
• Acute shock
• Chemotherapy within 4 weeks before start of the trial
• Chemotherapy during the trial
• Subjects for whom the trial treatment is not appropriate
• Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study.
• Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study
• Prior inclusion in the present study
• Any other feature that in the opinion of the investigator should preclude study participation

Contacts and Locations

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Locations

Australia, New South Wales
North Shore Private Hospital
Saint Leonards, New South Wales, Australia, 2065
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Denmark
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, Denmark, 0 9000
Rigshospitalet, Department of Medical Gastroenterology
Copenhagen, Denmark, 0 2100
France
Hopital Beaujon
Clichy la Garenne, France, 92110
Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon
Lyon, France, 69437
Israel
Beilinson Medical Center, Department of Surgery "B"
Petah Tiqwa, Israel, 0 45100
Netherlands
University Medical Center
Nijmegen, Netherlands, 6500 HB
Poland
Wydzial Lekarski I Katedra Chirurgii Ogolnej
Krakow, Poland, 31-501
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warsaw, Poland, 00-416
United Kingdom
Hope Hospital
Manchester, United Kingdom, 0M6 8HD
University Hospital, Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH

Sponsors and Collaborators

Fresenius Kabi

Investigators

Principal Investigator:	Jon Shaffer, MD	Hope Hospital, Manchester, United Kingdom

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Ingrid Mueller, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00451646 History of Changes
Other Study ID Numbers:	05-SMOF-006
First Posted:	March 23, 2007
Last Update Posted:	August 27, 2010
Last Verified:	October 2008

Additional relevant MeSH terms:

Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous; Parenteral Nutrition Solutions; Pharmaceutical Solutions