Status:
COMPLETED
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Lead Sponsor:
Fresenius Kabi
Conditions:
Parenteral Nutrition
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 safet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00451646
Start Date
October 1 2007
End Date
November 1 2008
Last Update
August 27 2010
Active Locations (12)
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1
North Shore Private Hospital
Saint Leonards, New South Wales, Australia, 2065
2
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
3
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, Denmark, 0 9000
4
Rigshospitalet, Department of Medical Gastroenterology
Copenhagen, Denmark, 0 2100