跳至主要内容
临床试验/EUCTR2019-003276-39-ES
EUCTR2019-003276-39-ES进行中(未招募)1 期

iver impairment recovery related to parenteral nutrition with omega-3 fatty acids: randomized clinical trial.

VALL HEBRON UNIVERSITY HOSPITA0 个研究点目标入组 117 人开始时间: 2019年10月21日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
117

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Age = 18 years.
  • Patients with at least 5 days of PN.
  • Baseline liver parameters before PN: GGT, alkaline phosphatase < 100 U/dL and direct bilirubin <1.2 mg/dL al inicio de NP.
  • Liver parameter alterations: GGT = 300 U/dL, alkaline phosphatase = 200 U/dL or direct bilirubin =1.8 mg/dL
  • Forseeing to receive at least 5 days of PN.
  • Admitted in the ICU of the Valle Hebron University Hospital
  • Willing to give their IC in writing for the trial and be able to do so.
  • 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 117
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 117

排除标准

  • - Lipids administration contraindicated
  • - Have a history of hypersensitivity of idiosincratic reactions to any component of intravenous lipid emulsions.
  • - Home parenteral nutrition patients
  • - Liver transplantation
  • - Liver parameters alterations before PN: 20% above upper normal values.
  • - Patients rejection to participate.

研究者

发起方
VALL HEBRON UNIVERSITY HOSPITA

相似试验