Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
- Conditions
- Parenteral Nutrition
- Interventions
- Drug: SMOF lipid and Intralipid
- Registration Number
- NCT00451646
- Lead Sponsor
- Fresenius Kabi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 SMOF lipid and Intralipid Intralipid 1 SMOF lipid and Intralipid SMOFlipid
- Primary Outcome Measures
Name Time Method 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 day 0, week 2, week 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Rigshospitalet, Department of Medical Gastroenterology
🇩🇰Copenhagen, Denmark
University Hospital, Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
North Shore Private Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Beilinson Medical Center, Department of Surgery "B"
🇮🇱Petah Tiqwa, Israel
Wydzial Lekarski I Katedra Chirurgii Ogolnej
🇵🇱Krakow, Poland
Aalborg University Hospital, Department of Medical Gastroenterology
🇩🇰Aalborg, Denmark
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
🇵🇱Warsaw, Poland
University Medical Center
🇳🇱Nijmegen, Netherlands
Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon
🇫🇷Lyon, France
Hopital Beaujon
🇫🇷Clichy la Garenne, France
Hope Hospital
🇬🇧Manchester, United Kingdom