Parenteral nutrition/malnutrition Nutritional, Metabolic, Endocrine Malnutrition
Conditions
Interventions
There were 48 patients per protocol from five European and two non-European countries. The interventions of this trial were the comparing of SMOFlipid 20% and Intralipid 20% on long-term treatment.
Sponsors
Fresenius Kabi Deutschland GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between 18 and 85 years of age 2. In- or out-patients unable to sustain an adequate oral/enteral food intake for at least four weeks and need of parenteral nutrition 3. Written informed consent from the subject
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to fish, egg or soy protein or to any of the active substances or excipients 2. Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. If the fasting S-triglyceride value at the time of inclusion is mopre than 3 mmol/l (>262.5 mg/dl) the subject must be withdrawn 3. Severe liver insufficiency 4. Severe blood coagulation disorders 5. Subjects with chronic stable renal insufficiency defined as S-creatinine value of more than 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy 6. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency 7. Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration) 8. Unstable angina pectoris 9. Acute shock 10. Chemotherapy within four weeks before start of the trial 11. Chemotherapy during the trial 12. Subjects for whom the trial treatment (amounts, contents etc.) is not appropriate 13. 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 (e.g. hormonal contraceptives, contraceptive coil) 14. 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 15. Prior inclusion in the present study 16. Any other feature that in the opinion of the investigator should preclude study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Laboratory variables: 1.1. Clinical chemistry parameters: triglycerides, total cholesterol AP, Aspartate Aminotransferase (AST - also known as S-GOT), gamma Glutamyl Transferase (g-GT), Alanine Aminotransferase (ALT - also known as S-GPT), sodium, potassium, chloride, magnesium, calcium, phosphate, total bilirubin, S-creatinine, urea, glucose, albumin, total protein, C-Reactive Protein 1.2. Haematology parameters: leucocytes, platelets, erythrocytes, haemoglobin, haematocrit, 1.3. Coagulation parameters: International Normalised Ratio (INR) 2. Adverse events 3. Vital signs: blood pressure (mmHg), heart rate (beats/min), body temperature (°C) 4. Lipid metabolism Rating of the safety and tolerance variables will be according to Common Terminology Criteria for Adverse Events. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Australia, Denmark, France, Israel, Netherlands, Poland, United Kingdom
Outcome results
None listed