Efficacy and safety of omega – 3 based lipid solution (Omegaven) in comparison with Lipofundin LCT/MCT in reducing cholestasis in children on parenteral nutrition – randomized double – blind clinical trial - OC TP

Children's Memorial Health Institute0 个研究点开始时间: 2009年3月23日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•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

•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 <95%, capillary refill nail test >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

发起方

Children's Memorial Health Institute