Sepsis, Endothelial function, and Lipids in critically ill patients with Liver Failure (SELLIFA). Nutritional sub-study : Randomized controlled trial comparing the tolerance on lipid metabolism and safety of isocaloric parenteral nutrition with enteral nutrition. - SELLIFA nutritional trial

Conditions: iver failure, Liver cirrhosis, critical illness, total nutritional support
MedDRA version: 9.1Level: LLTClassification code 10009211Term: Cirrhosis liver

Registration Number: EUCTR2007-002940-86-BE

Lead Sponsor: Cliniques Universitaires Saint-Luc – Université catholique de Louvain

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 more than 6 mmol/l (545 mg/dL), severe diabetic ketoacidosis ;
- Age less than 18 years and more than 85 ;
- Pregnancy, including HELLP syndrome ;
- Active malignancy with metastases (localised hepatocellular carcinoma is not an exclusion criteria);
- Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localised hepatocellular carcinoma is not an exclusion criteria) ;
- Acquired immunodeficiency syndrome and antiretroviral therapy