Safety and Tolerance on Lipids of Parenteral and Enteral Nutrition in Critically Ill Patients With Liver Failure
Condition: Liver Failure; Critical Illness
MeSH terms: Liver Failure; Hepatic Insufficiency; Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the tolerance on lipid metabolism and the safety of
      short-term parenteral nutrition as compared to enteral nutrition in critically ill patients
      with liver failure.
    

Detailed description: 
      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%.
    

Intervention name(s): Parenteral nutrition; Enteral nutrition
Intervention type(s): Other; Other
Intervention description(s): Duration : 5 days; Duration : 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver failure; Liver cirrhosis; Parenteral nutrition; Enteral nutrition; Lipids; Safety; Drug tolerance