The HOME Study (HPN With OMEGA-3)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2022-07-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Requiring Home Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lipidem

i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)

Group Type EXPERIMENTAL

Lipidem

Intervention Type DRUG

Lipoplus i.v. lipid emulsion for parenteral nutrition

Lipofundin MCT

i.v. lipid emulsion

Group Type ACTIVE_COMPARATOR

Lipofundin MCT 20%

Intervention Type DRUG

Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

Interventions

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Lipidem

Lipoplus i.v. lipid emulsion for parenteral nutrition

Intervention Type DRUG

Lipofundin MCT 20%

Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No