Clinical trial to investigate safety and efficacy of an Omega-3-fatty acid triglycerides (fish-oil”) enriched lipid emulsion in comparison to a lipid emulsion not containing fish-oil” in home parenteral nutrition in adults

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

1. Signed informed consent available
2. Male or female patients = 18 years of age
3. Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months
4. Patients receiving = 3.0 g lipids/kg body weight per week
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Persistent high total bilirubin values in medical history of the last 6 months (> 40µmol/l)
2. Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
3. Patients with history of cancer and anti-cancer treatment within the last 2 years
4. Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients
5. Patients treated in the past or currently with Teduglutide
6. Contraindications to investigational products (if available from medical records) including:
- Severe hyperlipidemia, including severe hypertriglyceridaemia (= 1000 mg/dl or 11.4 mmol/l)
- Severe coagulopathy
- Intrahepatic cholestasis
- Severe hepatic insufficiency
- Severe renal insufficiency in absence of renal replacement therapy
- Acute thromboembolic events
- Fat embolism
- Aggravating haemorrhagic diatheses
- Metabolic acidosis
7. General contraindications to parenteral nutrition (if available from medical records) including:
- Unstable circulatory status with vital threat (states of collapse and shock)
- Acute phase of cardiac infarction or stroke
- Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin)
- Inadequate cellular oxygen supply
- Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and hypotonic dehydration)
- Acute pulmonary edema
- Decompensated cardiac insufficiency
8. Positive test for HIV, Hepatitis B or C (from medical history)
9. Known or suspected drug or alcohol abuse
10. Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
11. Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
12. Any medical condition that in the opinion of the investigator might put the subject at risk or interfere with patients participation
For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not post-menopausal)
13. Women of childbearing potential tested positive on standard pregnancy test (urine dipstick)
14. Lactation
15. Women of childbearing potential who do not agree to apply adequate contraception
16. Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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