Safety and Tolerance on Lipids of Parenteral and Enteral Nutrition in Critically Ill Patients With Liver Failure (SELLIFA)
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|ClinicalTrials.gov Identifier: NCT00522730|
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : September 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure Critical Illness||Other: Parenteral nutrition Other: Enteral nutrition||Phase 4|
An impaired lipid metabolism is often found in patients with liver disease and is assumed to influence the prognosis. The central role of lipid metabolism in the pathophysiology of fatty liver disease and steatohepatitis is well established. In cirrhotic patients, serum lipid levels are mostly decreased and related to the severity of liver failure; in addition, the structure and composition of lipoproteins differ from that of healthy individuals. A reduction in high-density lipoproteins has been associated with higher cytokines levels and a poorer clinical outcome in septic patients. Furthermore, the oxidative stress induced by septic complications in critically ill patients with liver failure may lead to further hepatocellular injury and activation of systemic inflammation cascade.
In this setting, the influence of nutrition on lipid metabolism may have an impact on the severity of liver failure and associated complications. Although plasma clearance and oxidation of lipids were considered to be normal in the majority of patients with cirrhosis, most previous studies only reported the effects of an oral ingestion or parenteral infusion of lipids during a few hours.
The present randomized controlled trial will be conducted in a subgroup of patients enrolled in the SELLIFA-01 prospective study (NCT00488917). The purpose of the nutritional trial is to determine the tolerance on lipid metabolism and the safety of isocaloric short-term parenteral nutrition as compared to enteral nutrition in critically ill septic and non septic patients with liver failure. The nutrition will be delivered continuously for 5 days and will provide a daily energy supply corresponding to current resting energy expenditure as determined by indirect calorimetry, with 35% of total energy requirements as lipids, 15% as proteins (maximum 1.2g/kg ideal body weight/day), and 50% as dextrose. A tight glucose control strategy will be implemented to avoid hyperglycemia.
The trial is designed to randomly assign 15 patients in each interventional group in order to detect more than 25% increase in plasma triglycerides levels with 80% statistical power for two-tailed type I error of 5%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (SELLIFA). Randomized Controlled Trial Comparing the Tolerance on Lipids and Safety of Isocaloric Parenteral Nutrition With Enteral Nutrition.|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Other: Parenteral nutrition
Duration : 5 days
Active Comparator: 2
Other: Enteral nutrition
Duration : 5 days
- Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a) [ Time Frame: within 5 days ]
- Incidence of hyperglycaemia [ Time Frame: within 5 days ]
- Alteration of liver function [ Time Frame: within 5 and 28 days ]
- Gastrointestinal intolerance [ Time Frame: within 5 days ]
- Gastrointestinal bleeding [ Time Frame: within 5 and 28 days ]
- Septic complications [ Time Frame: within 5 and 28 days ]
- Occurence of new organ dysfunction [ Time Frame: within 5 and 28 days ]
- Length of stay in the intensive care unit (ICU) [ Time Frame: within 5 and 28 days ]
- Mortality [ Time Frame: within 5 and 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522730
|Departement of intensive care, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain|
|Brussels, Belgium, 1200|
|Study Director:||Pierre-François Laterre, MD||Cliniques universitaires Saint-Luc- Université Catholique de Louvain|
|Principal Investigator:||Yvan Fleury, MD||Cliniques universitaires Saint-Luc- Université Catholique de Louvain|