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Safety and Tolerance on Lipids of Parenteral and Enteral Nutrition in Critically Ill Patients With Liver Failure (SELLIFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00522730
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : September 3, 2009
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE August 29, 2007
First Posted Date  ICMJE August 30, 2007
Last Update Posted Date September 3, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a) [ Time Frame: within 5 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a). [ Time Frame: within 5 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
  • 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 ICU [ Time Frame: within 5 and 28 days ]
  • Mortality [ Time Frame: within 5 and 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerance on Lipids of Parenteral and Enteral Nutrition in Critically Ill Patients With Liver Failure
Official Title  ICMJE 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.
Brief 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%.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Failure
  • Critical Illness
Intervention  ICMJE
  • Other: Parenteral nutrition
    Duration : 5 days
  • Other: Enteral nutrition
    Duration : 5 days
Study Arms  ICMJE
  • Experimental: 1
    Parenteral nutrition
    Intervention: Other: Parenteral nutrition
  • Active Comparator: 2
    Enteral nutrition
    Intervention: Other: Enteral nutrition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2009)
45
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2007)
30
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00522730
Other Study ID Numbers  ICMJE SELLIFA-02
B40320072194
EudraCT n°2007-002940-86
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre-François Laterre, MD, Cliniques universitaires Saint-Luc, Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP