Liver failure, Liver cirrhosis, critical illness, total nutritional support MedDRA version: 9.1 Level: LLT Classification code 10009211 Term: Cirrhosis liver
Conditions
Interventions
Trade Name: Structolipid 20%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Triglycerids
CAS Number: 8000029085
Current Sponsor code: parenteral lipids
Concentration unit: % percent
C
Sponsors
Cliniques Universitaires Saint-Luc – Université catholique de Louvain
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose 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 cirrhosis. Patients unable to have a normal oral diet are eligible if a total nutritional support is planned. The nutrition will be delivered continuously over 24 hours for 5 days and will provide a daily energy supply corresponding to current resting energy expenditure, as measured by daily indirect calorimetry. 35% of energy needs will be provided as lipids, and 65% as glucose and proteins with a maximum of 1.2 g proteins/kg ideal body weight/day. Overall, 30 patients will be randomly assigned to either group in order to detect a 25% increase in plasma triglycerides with 80% statistical power for type I error of 5%. An interim analysis will be performed after 10 patients in order to assess the tolerance on lipid metabolism and safety of both types of nutrition.;Secondary Objective: To determine the relationship between changes in lipid pattern and prognosis.;Primary end point(s): Primary endpoint of the trial is to evaluate the tolerance and safety of isocaloric short-term parenteral versus enteral nutrition on lipid metabolism. Secondary endpoints are the incidence of alteration of liver function, other metabolic disturbances, septic complications, nutrition delivery problems, occurrence of new organ dysfunction, length of stay in the ICU, and mortality | — |
Countries
Belgium
Outcome results
None listed