EUCTR2020-000705-86-ES进行中(未招募)1 期
Control of inflammatory parameters with omega-3 fatty acid supplementation in adult patients with parenteral nutrition and respiratory infection by SARS-CoV-2: randomized clinical trial COVID-19
VALL HEBRON UNIVERSITY HOSPITA0 个研究点目标入组 117 人开始时间: 2020年5月5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
- 性别
- All
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
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