Evidence map›Paper›PMID 31888740›Full record

ArticleTrials2019

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.

Stanislaw Klek, Cécile Chambrier, Sheldon C Cooper, Simon Gabe, Marek Kunecki, Loris Pironi, Farooq Rahman, Jacek Sobocki, Kinga Szczepanek, Geert Wanten and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03282955 (A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03282955 phase4completednot on this map

A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion

TypeinterventionalSponsorB. Braun Melsungen AGRan2018 to 2022Enrolled74ConditionsPatients Requiring Home Parenteral NutritionArmsLipidem, Lipofundin MCT 20%
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 7 countries.

Stanislaw KlekStanley Dudrick's Memorial Hospital, General and Oncology Surgery Unit, 15 Tyniecka Street, 32-050, Skawina, Poland. klek@poczta.onet.pl.ORCID http://orcid.org/0000-0002-7887-3464
Cécile ChambrierHospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet, 69495, Pierre-Benite, France.
Sheldon C CooperGI Medicine - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Mindelsohn Way, Birmingham, B15 2TH, UK.
Simon GabeSt Mark's Hospital, Northwick Park, Watford Road, Harrow, HA1 3UJ, UK.
Marek KuneckiWojewódzki Specjalistyczny Szpital im. M. Pirogowa w Łodzi, Oddział Chirurgii Ogólnej i Naczyniowej, ul. Wólczańska 191/195, 90-531, Łódź, Poland.
Loris PironiDepartment of Medical and Surgical Science, University of Bologna, St. Orsola-Malpighi Hospital, Via Massarenti, 9, 40138, Bologna, Italy.
Farooq RahmanUniversity College Hospital, 250 Euston Road, London, NW1 2PG, UK.
Jacek SobockiSamodzielny Publiczny Szpital Kliniczny im. Prof. dr W. Orlowskiego, Oddzial Kliniczny Zywienia i Chirurgii, ul. Czerniakowska 231, 00-416, Warszawa, Poland.
Kinga SzczepanekStanley Dudrick's Memorial Hospital, General and Oncology Surgery Unit, 15 Tyniecka Street, 32-050, Skawina, Poland.
Geert WantenRadboud Universitair Medisch Centrum, Afdeling Maag-, Darm- en Leverziekten, Postbus 9101, 6500 HB, Nijmegen, The Netherlands.
Nicole LinckeMedical Scientific Affairs, B. Braun Melsungen AG, Carl-Braun-Str. 1, 34212, Melsungen, Germany.
Bernhard GlotzbachMedical Scientific Affairs, B. Braun Melsungen AG, Carl-Braun-Str. 1, 34212, Melsungen, Germany.
Alastair ForbesFaculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
B. Braun (Germany) · DEMemorial Hospital · USHospices Civils de Lyon · FRIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITRadboud University Nijmegen · NLSamodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego CMKP · PLSt Mark's Hospital · GBUniversity College Hospital · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of East Anglia · GBWojewódzki Szpital Specjalistyczny we Wrocławiu · PL

Funding

B. Braun Melsungen No
6 · The paper itself

Abstract

backgroundHome 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/

designThe 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: 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 registrationClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.

Indexed as

Fat Emulsions, IntravenousFatty Acids, Omega-3Malabsorption SyndromesParenteral Nutrition, HomePhospholipidsSorbitolTriglyceridesAdolescentAdultAgedAged, 80 and overAlanine TransaminaseAspartate AminotransferasesBilirubinDouble-Blind MethodDrug CombinationsAlanine TransaminaseAspartate AminotransferasesBilirubinDrug CombinationsFat Emulsions, IntravenousFatty Acids, Omega-3LipofundinPhospholipidsSorbitolTriglyceridesChronic intestinal failureHome parenteral nutritionIntravenous lipid emulsionLiver functionOmega-3 PUFARandomized controlled trial

Identifiers

PMID31888740
PMCPMC6938010
OpenAlexW2998266538

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.