Clinical trial NCT03282955: The HOME Study (HPN With OMEGA-3)
Official title: A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Requiring Home Parenteral Nutrition
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Change of liver function parameters from baseline to visit 2
timeFrame: 8 weeks
Secondary outcomes:
measure: Bilirubin
timeFrame: 8 weeks
measure: Alanine transaminase (ALT)
timeFrame: 8 weeks
measure: Aspartate transaminase (AST)
timeFrame: 8 weeks
measure: AST/ALT ratio
timeFrame: 8 weeks
measure: Alkaline phosphatase (ALP)
timeFrame: 8 weeks
measure: Gamma-glutamyl transpeptidase (GGT)
timeFrame: 8 weeks
measure: White blood cells (WBCs)
timeFrame: 8 weeks
measure: Red blood cells (RBCs)
timeFrame: 8 weeks
measure: Hemoglobin (Hb)
timeFrame: 8 weeks
measure: Platelets
timeFrame: 8 weeks
measure: International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted)
timeFrame: 8 weeks
measure: Activated partial thromboplastin time (aPTT)
timeFrame: 8 weeks
measure: Hematocrit (Hct)
timeFrame: 8 weeks
measure: Blood glucose
timeFrame: 8 weeks
measure: Sodium
timeFrame: 8 weeks
measure: Cloride
timeFrame: 8 weeks
measure: Potassium
timeFrame: 8 weeks
measure: Calcium
timeFrame: 8 weeks
measure: Magnesium
timeFrame: 8 weeks
measure: Phosphate
timeFrame: 8 weeks
measure: Serum creatinine
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: Cholesterol
timeFrame: 8 weeks
measure: High-density lipoprotein (HDL)
timeFrame: 8 weeks
measure: Low-density lipoprotein (LDL)
timeFrame: 8 weeks
measure: C-reactive protein (CRP)
timeFrame: 8 weeks
measure: α-Tocopherol/Vitamin E (facultative if routinely assessed)
timeFrame: 8 weeks
measure: Fatty acid pattern in plasma and RBCs
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Archet 2 - Unité de support nutritionnel
city: Pierre-Bénite
country: France
facility: Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
city: Bologna
country: Italy
facility: Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii
city: Łódź
country: Poland
facility: Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: University College Hospital London
Study officials:
References:
citation: Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z.