Safety and Tolerance on Lipids of Parenteral and Enteral Nutrition in Critically Ill Patients With Liver Failure - Full Text View

Sponsor:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00522730

Purpose

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.

Condition	Intervention	Phase
Liver Failure Critical Illness	Other: Parenteral nutrition Other: Enteral nutrition	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Lipids

U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:

Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a) [ Time Frame: within 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of hyperglycaemia [ Time Frame: within 5 days ] [ Designated as safety issue: Yes ]
Alteration of liver function [ Time Frame: within 5 and 28 days ] [ Designated as safety issue: Yes ]
Gastrointestinal intolerance [ Time Frame: within 5 days ] [ Designated as safety issue: No ]
Gastrointestinal bleeding [ Time Frame: within 5 and 28 days ] [ Designated as safety issue: Yes ]
Septic complications [ Time Frame: within 5 and 28 days ] [ Designated as safety issue: Yes ]
Occurence of new organ dysfunction [ Time Frame: within 5 and 28 days ] [ Designated as safety issue: Yes ]
Length of stay in the intensive care unit (ICU) [ Time Frame: within 5 and 28 days ] [ Designated as safety issue: No ]
Mortality [ Time Frame: within 5 and 28 days ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	August 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Parenteral nutrition	Other: Parenteral nutrition Duration : 5 days
2: Active Comparator Enteral nutrition	Other: Enteral nutrition Duration : 5 days

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%.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All consecutive patients with a diagnosis of chronic liver failure;
Planned total nutritional support;
Adult patient aged 18 years or above, and less than 85;
Admission to the ICU for an expected period of > 24 hours;
Informed consent of the patient or nearest relative.

Exclusion Criteria:

Absolute contra-indications to enteral nutrition : total mechanical ileus, persistent vomiting, high output fistulas, uncertain gastrointestinal anastomosis;
Absolute contra-indications to parenteral nutrition : severe hypertriglyceridemia > 6 mmol/l (> 545 mg/dL), severe diabetic ketoacidosis;
Age less than 18 years or more than 85;
Pregnancy, including HELLP syndrome;
Active malignancy with metastases (localized hepatocellular carcinoma is not an exclusion criteria);
Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localized hepatocellular carcinoma is not an exclusion criteria);
Acquired immunodeficiency syndrome and antiretroviral therapy;
Refusal of the patient or nearest relative.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522730

Locations

Belgium
Departement of intensive care, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain
Brussels, Belgium, 1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

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

More Information

No publications provided

Responsible Party:	Cliniques universitaires Saint-Luc, Université Catholique de Louvain ( Pierre-François Laterre, MD )
Study ID Numbers:	SELLIFA-02, B40320072194, EudraCT n°2007-002940-86
Study First Received:	August 29, 2007
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00522730 History of Changes
Health Authority:	Belgium: Institutional Review Board; Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Liver failure
Liver cirrhosis
Parenteral nutrition
Enteral nutrition

Lipids
Safety
Drug tolerance

Additional relevant MeSH terms:

Liver Failure
Liver Diseases
Disease Attributes
Digestive System Diseases

Pathologic Processes
Critical Illness
Hepatic Insufficiency

ClinicalTrials.gov processed this record on February 08, 2010