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

Fresenius Kabi

Status and phase

Completed

Phase 3

Conditions

Parenteral Nutrition

Treatments

Drug: SMOF lipid and Intralipid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00451646

05-SMOF-006

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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