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.
Adolescent
Adult
Aged
Aged, 80 and over
Female
Humans
Male
Middle Aged
Young Adult
Alanine Transaminase
/ blood
Aspartate Aminotransferases
/ blood
Bilirubin
/ blood
Double-Blind Method
Drug Combinations
Fat Emulsions, Intravenous
/ adverse effects
Fatty Acids, Omega-3
/ administration & dosage
Liver Function Tests
/ methods
Malabsorption Syndromes
/ blood
Parenteral Nutrition, Home
/ methods
Phospholipids
/ adverse effects
Prospective Studies
Randomized Controlled Trials as Topic
Sorbitol
/ adverse effects
Treatment Outcome
Triglycerides
/ administration & dosage
Multicenter Studies as Topic
Chronic intestinal failure
Home parenteral nutrition
Intravenous lipid emulsion
Liver function
Omega-3 PUFA
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
30 Dec 2019
30 Dec 2019
Historique:
received:
27
09
2019
accepted:
12
12
2019
entrez:
1
1
2020
pubmed:
1
1
2020
medline:
22
9
2020
Statut:
epublish
Résumé
Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited. The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs. Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.
METHODS/DESIGN
METHODS
The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs.
DISCUSSION
CONCLUSIONS
Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.
Identifiants
pubmed: 31888740
doi: 10.1186/s13063-019-3994-z
pii: 10.1186/s13063-019-3994-z
pmc: PMC6938010
doi:
Substances chimiques
Alanine Transaminase
EC 2.6.1.2
Aspartate Aminotransferases
EC 2.6.1.1
Bilirubin
RFM9X3LJ49
Drug Combinations
0
Fat Emulsions, Intravenous
0
Fatty Acids, Omega-3
0
Lipofundin
11096-66-5
Phospholipids
0
Sorbitol
506T60A25R
Triglycerides
0
Banques de données
ClinicalTrials.gov
['NCT03282955']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
808Subventions
Organisme : B. Braun Melsungen
ID : No
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