Clinical trial NCT00451646: Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Official title: A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2007-03-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: day 0, week 2, week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Department of Medical Gastroenterology
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Department of Medical Gastroenterology
city: Clichy la Garenne
country: France
facility: Hopital Beaujon
city: Lyon
country: France
facility: Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon
city: Petah Tiqwa
country: Israel
facility: Beilinson Medical Center, Department of Surgery "B"
city: Nijmegen
country: Netherlands
facility: University Medical Center
city: Krakow
country: Poland
facility: Wydzial Lekarski I Katedra Chirurgii Ogolnej
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
city: Manchester
country: United Kingdom
facility: Hope Hospital
city: Nottingham
country: United Kingdom
facility: University Hospital, Queen's Medical Centre
Study officials:
affiliation: Hope Hospital, Manchester, United Kingdom
name: Jon Shaffer, MD
role: PRINCIPAL_INVESTIGATOR
References: