The HOME Study (HPN With OMEGA-3)

B. Braun

Status and phase

Completed

Phase 4

Conditions

Patients Requiring Home Parenteral Nutrition

Treatments

Drug: Lipidem

Drug: Lipofundin MCT 20%

Study type

Interventional

Funder types

Industry

Identifiers

NCT03282955

HC-G-H-1403

Details and patient eligibility

About

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

Signed informed consent available
Male or female patients ≥ 18 years of age
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
Patients receiving ≥ 3.0 g lipids/kg body weight per week

Exclusion:

Persistent high total bilirubin values in medical history of last 6 months (> 40µmol/l)
Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
Patients with history of cancer and anti-cancer treatment within the last 2 years
Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients
Patients treated in the past or currently with Teduglutide
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
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
Positive test for HIV, Hepatitis B or C (from medical history)
Known or suspected drug or alcohol abuse
Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
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)
Women of childbearing potential tested positive on standard pregnancy test (urine dipstick)
Lactation
Women of childbearing potential who do not agree to apply adequate contraception
Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent