The HOME Study (HPN With OMEGA-3)

Patients Requiring Home Parenteral Nutrition Clinical Trial

— HOME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282955
• Other study ID #: HC-G-H-1403
• Status: Completed
• Phase: Phase 4
• Start date: January 8, 2018
• Est. completion date: July 19, 2022

Study information

• Verified date: September 2022
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Requiring Home Parenteral Nutrition

Intervention

Drug:
• Lipidem
Lipoplus i.v. lipid emulsion for parenteral nutrition
• Lipofundin MCT 20%
Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

Locations

Country	Name	City	State
France	Hôpital Archet 2 - Unité de support nutritionnel	Nice
France	Hospices Civiles de Lyon - Centre hospitalier Lyon Sud	Pierre-Bénite
Italy	Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital	Bologna
Netherlands	Radboud university medical center	Nijmegen
Poland	Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Lodzi , Oddzial Chirurgii Ogólnej i Naczyniowej	Lódz
Poland	Stanley Dudrick's Memorial Hospital	Skawina
Poland	Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii	Warszawa
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	University College Hospital London	London

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of liver function parameters from baseline to visit 2	Changes will be expressed as the sum of the N(0.1)-transformed differences of bilirubin, ALT and AST (visit 2 - baseline).	8 weeks
Secondary	Bilirubin		8 weeks
Secondary	Alanine transaminase (ALT)		8 weeks
Secondary	Aspartate transaminase (AST)		8 weeks
Secondary	AST/ALT ratio		8 weeks
Secondary	Alkaline phosphatase (ALP)		8 weeks
Secondary	Gamma-glutamyl transpeptidase (GGT)		8 weeks
Secondary	White blood cells (WBCs)		8 weeks
Secondary	Red blood cells (RBCs)		8 weeks
Secondary	Hemoglobin (Hb)		8 weeks
Secondary	Platelets		8 weeks
Secondary	International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted)		8 weeks
Secondary	Activated partial thromboplastin time (aPTT)		8 weeks
Secondary	Hematocrit (Hct)		8 weeks
Secondary	Blood glucose		8 weeks
Secondary	Sodium		8 weeks
Secondary	Cloride		8 weeks
Secondary	Potassium		8 weeks
Secondary	Calcium		8 weeks
Secondary	Magnesium		8 weeks
Secondary	Phosphate		8 weeks
Secondary	Serum creatinine		8 weeks
Secondary	Triglycerides		8 weeks
Secondary	Cholesterol		8 weeks
Secondary	High-density lipoprotein (HDL)		8 weeks
Secondary	Low-density lipoprotein (LDL)		8 weeks
Secondary	C-reactive protein (CRP)		8 weeks
Secondary	a-Tocopherol/Vitamin E (facultative if routinely assessed)		8 weeks
Secondary	Fatty acid pattern in plasma and RBCs	Fatty acid pattern in plasma and RBCs, triene:tetraene ratio obtained from fatty acid pattern in plasma	8 weeks
Secondary	Adverse events		8 weeks
Secondary	BMI	Body mass index	8 weeks