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

Study Overview
=================
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.

Official Title
-----------------
A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Conditions
-----------------
Parenteral Nutrition

Intervention / Treatment
-----------------
* Drug: SMOF lipid and Intralipid


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SMOFlipid | Drug: SMOF lipid and Intralipid<br>* 1-2 g, 5-7 days, 28 days<br>|
| Active Comparator: 2<br>Intralipid | Drug: SMOF lipid and Intralipid<br>* 1-2 g, 5-7 days, 28 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |