Parenteral nutrition associated liver disease (PNALD) MedDRA LLT: total parenteral nutrition MedDRA PT: parenteral nutrition MedDRA LLT: liver cholestasis MedDRA PT: cholestasis
Conditions
Interventions
Trade Name: Lipofundin MCT/LCT
Pharmaceutical Form: Emulsion for infusion
Trade Name: Omegaven
Pharmaceutical Form: Emulsion for infusion
Sponsors
Children's Memorial Health Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 0 – 18 years. 2. Informed consent signed by a parent (legal guardian) before the beginning of the study. 3. Cholestasis connected with parenteral nutrition defined as increase of conjugated bilirubin >2 mg/dl and GGTP >55 U/l at least for two weeks of parenteral nutrition. Exclusion of another etiologies: toxoplasma gondi, listeria monocytogenes, rubella virus, HSV, CMV, HBV,HCV, anatomic anomalies confirmed by ultrasonography. 4. Parenteral nutrition at least for 21 days. 5. Expected parenteral nutrition time for at least 4 months Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Cholestasis conected with other than parenteral nutrition confirmed factor. 2. Renal failure: creatinine > 1 mg/dl, urea > 40 mg/dl. 3. Dysfunction of blood coagulation: INR>2, PT> 20. 4. Respiratory-circulatory insufficiency: tachycardia*, decrease of blood pressure*, decrease of blood saturation 2s. 5. Suspicion of egg or fish protein allergy. 6. Urinary tract infection: leucocyturia, positive bacteriological urine culture. 7. Suspicion of cystic fibrosis: sweat concentration of Cl > 60 mmol/l. 8. Suspicion of hypothyroidism: FT4 < 0,8 ng/dl, abnormal level of TSH ( N: 0,4-4 uIU/ml). 9. Suspicion of sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to asses efficiency and safety of use of Omegaven emulsion in comparison with Lipofundin LCT/MCT in treatment of parenteral nutrition – associated liver disease in children with bowel dysfunction;Secondary Objective: To asses the influence of studied lipid emulsion on growth and nutritional status assessed by changes in the anthropometric measurement;Primary end point(s): The primary study outcome is the incidence of cholestasis reversal defined as serum level of direct bilirubin measurement < 2mg/dl. | — |
Countries
Poland
Outcome results
None listed