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:
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
- 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
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