Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00451646 |
Recruitment Status :
Completed
First Posted : March 23, 2007
Last Update Posted : August 27, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parenteral Nutrition | Drug: SMOF lipid and Intralipid | Phase 3 |
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 |

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 |
- 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 ]

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

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): NCT00451646
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 |
Principal Investigator: | Jon Shaffer, MD | Hope Hospital, Manchester, United Kingdom |
Responsible Party: | Dr. Ingrid Mueller, Fresenius Kabi Deutschland GmbH |
ClinicalTrials.gov Identifier: | NCT00451646 |
Other Study ID Numbers: |
05-SMOF-006 |
First Posted: | March 23, 2007 Key Record Dates |
Last Update Posted: | August 27, 2010 |
Last Verified: | October 2008 |
Soybean oil, phospholipid emulsion Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |