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临床试验/EUCTR2018-002447-29-AT
EUCTR2018-002447-29-AT进行中(未招募)1 期

THE ENTERAL RESUSCITATION IN INTENSIVE CARE STUDY

Medizinische Universität Wien, klinische Abteilung für Nephrologie und Dialyse0 个研究点目标入组 64 人开始时间: 2018年7月10日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
64

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

  • (1) Newly intubated patients (<72h)
  • (2) Age >18 years
  • (3) Amount of fluid substitution was within the range as defined for the respective disease per Table 2 in clinical study protocol
  • (4) Negative pregnancy test in female patients of childbearing potential
  • (5) Informed consent
  • (6) Expected required fluid volume may not exceed 4 mL/kg/h (permanently, during at least 24 hours)
  • (7) For patients that are temporarily unable to consent a subsequent informed consent has to be provided.
  • 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 32
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 32

排除标准

  • (1) Evidence of severe gastrointestinal disease defined as:
  • - Gastrointestinal Failure score > 3 or
  • - lactate >3mmol/L when mesenterial ischemia is a probable cause or
  • - intraabdominal pressure >20mmHg or increase under enteral fluid/nutrition administration)
  • (2) Patients who cannot receive early enteral nutrition due to conditions such as prone positioning in consequence of conditions such as acute respiratory distress syndrome
  • (3) Pregnancy
  • (4) Abdominal surgery in the last 3 months (unless all involved physicians – study investigators and caretaking doctors – agree that the surgical event does not constitute a limitation for enteral fluid administration)
  • (5) Postoperative patients
  • (6) At the discretion of the Investigator

研究者

发起方
Medizinische Universität Wien, klinische Abteilung für Nephrologie und Dialyse

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