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

Critical Illness Clinical Trial

— SELLIFA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522730
• Other study ID #: SELLIFA-02
• Secondary ID: B40320072194Eudr
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2007
• Last updated: September 2, 2009
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Liver Failure

Intervention

Other:
• Parenteral nutrition
Duration : 5 days
• Enteral nutrition
Duration : 5 days

Locations

Country	Name	City	State
Belgium	Departement of intensive care, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a)		within 5 days	Yes
Secondary	Incidence of hyperglycaemia		within 5 days	Yes
Secondary	Alteration of liver function		within 5 and 28 days	Yes
Secondary	Gastrointestinal intolerance		within 5 days	No
Secondary	Gastrointestinal bleeding		within 5 and 28 days	Yes
Secondary	Septic complications		within 5 and 28 days	Yes
Secondary	Occurence of new organ dysfunction		within 5 and 28 days	Yes
Secondary	Length of stay in the intensive care unit (ICU)		within 5 and 28 days	No
Secondary	Mortality		within 5 and 28 days	No