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临床试验/EUCTR2011-002547-94-DK
EUCTR2011-002547-94-DK进行中(未招募)1 期

Early Goal-Directed Nutrition in ICU Patients – EAT-ICU Trial - EAT-ICU Trial

Dept. of Intensive Care 4131, Rigshospitalet0 个研究点目标入组 200 人开始时间: 2013年3月25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
200

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

  • Patients will be randomised as soon as possible, and included and dosed at the latest 24 hours after admission to the ICU. Patients must meet all of the following criteria to be eligible for inclusion:
  • 1.Age = 18 years
  • 2.Acutely admitted to the ICU
  • 3.Expected length of stay in ICU > 3 days
  • 4.Mechanically ventilated, which enables indirect calorimetry
  • 5.Have a central venous catheter wherein PN can be administered
  • 6.Written informed consent obtained
  • 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 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Patients with one or more of the listed conditions will not be included, as they may have unique nutritional requirements:
  • ?Contraindications to use enteral nutrition
  • ?Burns > 10% total body surface area
  • ?Severe hepatic failure (Child-Pugh class C) or severe hepatic dysfunction: Bilirubin = 50 µmol/l (3 mg/dl) + alanine aminotransferase = 3 times upper reference value
  • ?Traumatic brain injury
  • ?Diabetic ketoacidosis
  • ?Hyperosmolar non-ketotic acidosis
  • ?Known or suspected hyperlipidemia
  • ?BMI ? 17 or severe malnutrition
  • ?The clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent

研究者

发起方
Dept. of Intensive Care 4131, Rigshospitalet

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