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“A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection”
BACKGROUND: The body is dependent on the exogenous supply of omega-3 polyunsaturated fatty acids (n3-PUFA). These essential fatty acids are key players in regulating metabolic signaling but also exert anti-inflammatory and anti-carcinogenic properties. The liver is a major metabolic organ involved i...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4535369/ https://www.ncbi.nlm.nih.gov/pubmed/26268565 http://dx.doi.org/10.1186/s12876-015-0331-1 |
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author | Linecker, Michael Limani, Perparim Botea, Florin Popescu, Irinel Alikhanov, Ruslan Efanov, Michail Kim, Pavel Khatkov, Igor Raptis, Dimitri Aristotele Tschuor, Christoph Beck-Schimmer, Beatrice Bonvini, John Wirsching, Andrea Kron, Philipp Slankamenac, Ksenija Humar, Bostjan Graf, Rolf Petrowsky, Henrik Clavien, Pierre-Alain |
author_facet | Linecker, Michael Limani, Perparim Botea, Florin Popescu, Irinel Alikhanov, Ruslan Efanov, Michail Kim, Pavel Khatkov, Igor Raptis, Dimitri Aristotele Tschuor, Christoph Beck-Schimmer, Beatrice Bonvini, John Wirsching, Andrea Kron, Philipp Slankamenac, Ksenija Humar, Bostjan Graf, Rolf Petrowsky, Henrik Clavien, Pierre-Alain |
author_sort | Linecker, Michael |
collection | PubMed |
description | BACKGROUND: The body is dependent on the exogenous supply of omega-3 polyunsaturated fatty acids (n3-PUFA). These essential fatty acids are key players in regulating metabolic signaling but also exert anti-inflammatory and anti-carcinogenic properties. The liver is a major metabolic organ involved in fatty acid metabolism. Under experimental conditions, n3-PUFA exert beneficial effect on hepatic steatosis, regeneration and inflammatory insults such as ischemic injury after surgery. Some of these effects have also been observed in human subjects. However, it is unclear whether perioperative administration of n3-PUFA is sufficient to protect the liver from ischemic injury. Therefore, we designed a randomized controlled trial (RCT) assessing n3-PUFA (pre-) conditioning strategies in patients scheduled for liver surgery. METHODS/DESIGN: The Omegaven™ trial is a multi-centric, double-blind, randomized, placebo- controlled trial applying two single doses of Omegaven™ or placebo on 258 patients undergoing major liver resection. Primary endpoints are morbidity and mortality one month after hospital discharge, defined by the Clavien- Dindo classification of surgical complications (Ann Surg 240(2):205–13, 2004) as well as the Comprehensive Complication Index (CCI) (Ann Surg 258(1):1–7, 2013). Secondary outcome variables include length of Intensive Care Unit (ICU) and hospital stay, postoperative liver function tests, fatty acid and eicosanoid concentration, inflammatory markers in serum and in liver tissue. An interim analysis is scheduled after the first 30 patients per randomization group. DISCUSSION: Long-term administration of n3-PUFA have a beneficial effect on metabolism and hepatic injury. Patients often require surgery without much delay, thus long-term n3-PUFA uptake is not possible. Also, lack of compliance may lead to incomplete n3-PUFA substitution. Hence, perioperative Omegaven™ may provide an easy and controllable way to ensure hepaative application of tic protection. TRIAL REGISTRATION: ClinicalTrial.gov: ID: NCT01884948, registered June 14, 2013; Institution Ethical Board Approval: KEK-ZH-Nr. 2010–0038; Swissmedic Notification: 2012DR3215. |
format | Online Article Text |
id | pubmed-4535369 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-45353692015-08-14 “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” Linecker, Michael Limani, Perparim Botea, Florin Popescu, Irinel Alikhanov, Ruslan Efanov, Michail Kim, Pavel Khatkov, Igor Raptis, Dimitri Aristotele Tschuor, Christoph Beck-Schimmer, Beatrice Bonvini, John Wirsching, Andrea Kron, Philipp Slankamenac, Ksenija Humar, Bostjan Graf, Rolf Petrowsky, Henrik Clavien, Pierre-Alain BMC Gastroenterol Study Protocol BACKGROUND: The body is dependent on the exogenous supply of omega-3 polyunsaturated fatty acids (n3-PUFA). These essential fatty acids are key players in regulating metabolic signaling but also exert anti-inflammatory and anti-carcinogenic properties. The liver is a major metabolic organ involved in fatty acid metabolism. Under experimental conditions, n3-PUFA exert beneficial effect on hepatic steatosis, regeneration and inflammatory insults such as ischemic injury after surgery. Some of these effects have also been observed in human subjects. However, it is unclear whether perioperative administration of n3-PUFA is sufficient to protect the liver from ischemic injury. Therefore, we designed a randomized controlled trial (RCT) assessing n3-PUFA (pre-) conditioning strategies in patients scheduled for liver surgery. METHODS/DESIGN: The Omegaven™ trial is a multi-centric, double-blind, randomized, placebo- controlled trial applying two single doses of Omegaven™ or placebo on 258 patients undergoing major liver resection. Primary endpoints are morbidity and mortality one month after hospital discharge, defined by the Clavien- Dindo classification of surgical complications (Ann Surg 240(2):205–13, 2004) as well as the Comprehensive Complication Index (CCI) (Ann Surg 258(1):1–7, 2013). Secondary outcome variables include length of Intensive Care Unit (ICU) and hospital stay, postoperative liver function tests, fatty acid and eicosanoid concentration, inflammatory markers in serum and in liver tissue. An interim analysis is scheduled after the first 30 patients per randomization group. DISCUSSION: Long-term administration of n3-PUFA have a beneficial effect on metabolism and hepatic injury. Patients often require surgery without much delay, thus long-term n3-PUFA uptake is not possible. Also, lack of compliance may lead to incomplete n3-PUFA substitution. Hence, perioperative Omegaven™ may provide an easy and controllable way to ensure hepaative application of tic protection. TRIAL REGISTRATION: ClinicalTrial.gov: ID: NCT01884948, registered June 14, 2013; Institution Ethical Board Approval: KEK-ZH-Nr. 2010–0038; Swissmedic Notification: 2012DR3215. BioMed Central 2015-08-14 /pmc/articles/PMC4535369/ /pubmed/26268565 http://dx.doi.org/10.1186/s12876-015-0331-1 Text en © Linecker et al. 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Linecker, Michael Limani, Perparim Botea, Florin Popescu, Irinel Alikhanov, Ruslan Efanov, Michail Kim, Pavel Khatkov, Igor Raptis, Dimitri Aristotele Tschuor, Christoph Beck-Schimmer, Beatrice Bonvini, John Wirsching, Andrea Kron, Philipp Slankamenac, Ksenija Humar, Bostjan Graf, Rolf Petrowsky, Henrik Clavien, Pierre-Alain “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” |
title | “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” |
title_full | “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” |
title_fullStr | “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” |
title_full_unstemmed | “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” |
title_short | “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven™) on outcome after major liver resection” |
title_sort | “a randomized, double-blind study of the effects of omega-3 fatty acids (omegaven™) on outcome after major liver resection” |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4535369/ https://www.ncbi.nlm.nih.gov/pubmed/26268565 http://dx.doi.org/10.1186/s12876-015-0331-1 |
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