The HOME Study (HPN With OMEGA-3)

Phase 4

Completed

• Conditions: Patients Requiring Home Parenteral Nutrition
• Interventions: Drug: Lipidem; Drug: Lipofundin MCT 20%

• Registration Number: NCT03282955
• Lead Sponsor: B. Braun Melsungen AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Study Start: 2018-01-08
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipidem	Lipidem	i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)
Lipofundin MCT	Lipofundin MCT 20%	i.v. lipid emulsion

Primary Outcome Measures

Name	Time	Method
Change of liver function parameters from baseline to visit 2	8 weeks	Changes will be expressed as the sum of the N(0.1)-transformed differences of bilirubin, ALT and AST (visit 2 - baseline).

Secondary Outcome Measures

Name	Time	Method
High-density lipoprotein (HDL)	8 weeks
Low-density lipoprotein (LDL)	8 weeks
C-reactive protein (CRP)	8 weeks
Serum creatinine	8 weeks
Triglycerides	8 weeks
Bilirubin	8 weeks
Alanine transaminase (ALT)	8 weeks
Aspartate transaminase (AST)	8 weeks
Cholesterol	8 weeks
AST/ALT ratio	8 weeks
Alkaline phosphatase (ALP)	8 weeks
Gamma-glutamyl transpeptidase (GGT)	8 weeks
White blood cells (WBCs)	8 weeks
Red blood cells (RBCs)	8 weeks
Hemoglobin (Hb)	8 weeks
Platelets	8 weeks
International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted)	8 weeks
Activated partial thromboplastin time (aPTT)	8 weeks
Hematocrit (Hct)	8 weeks
Blood glucose	8 weeks
Sodium	8 weeks
Cloride	8 weeks
Potassium	8 weeks
Calcium	8 weeks
Magnesium	8 weeks
Phosphate	8 weeks
α-Tocopherol/Vitamin E (facultative if routinely assessed)	8 weeks
Fatty acid pattern in plasma and RBCs	8 weeks	Fatty acid pattern in plasma and RBCs, triene:tetraene ratio obtained from fatty acid pattern in plasma
Adverse events	8 weeks
BMI	8 weeks	Body mass index

Trial Locations

Locations (9)

Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii; 🇵🇱 Warszawa, Poland

Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej; 🇵🇱 Łódź, Poland

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland

University College Hospital London; 🇬🇧 London, United Kingdom

Hospices Civiles de Lyon - Centre hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands

Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital; 🇮🇹 Bologna, Italy

Hôpital Archet 2 - Unité de support nutritionnel; 🇫🇷 Nice, France