Status:
COMPLETED
The HOME Study (HPN With OMEGA-3)
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Patients Requiring Home Parenteral Nutrition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03282955
Start Date
January 8 2018
End Date
July 19 2022
Last Update
July 4 2025
Active Locations (9)
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1
Hôpital Archet 2 - Unité de support nutritionnel
Nice, France
2
Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
Pierre-Bénite, France
3
Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
Bologna, Italy
4
Radboud university medical center
Nijmegen, Netherlands