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临床试验/EUCTR2010-024225-20-DE
EUCTR2010-024225-20-DE进行中(未招募)1 期

The impact of phosphate balanced cristalloid infusion on acid-base homeostastis - PALANCE

niversity Hospital Munich, Germany0 个研究点目标入组 48 人开始时间: 2014年4月4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
48

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
Female

入选标准

  • only female patients who have given their informed consent
  • ASA I-III classified female patients, who are scheduled for an extended abdominal surgical procedure under general anesthesia with routinely planned placement of a central venous and arterial catheter
  • age = 18 years
  • 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 28
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • participation in another clinical trial
  • patients who are not personally able to giver their informed consent
  • patients at a childbearing age without using contraceptives
  • acute or chronic renal failiure (glomerular filtration rate <60ml/min)
  • patients suffering from acid-base-dysregulation (i.e. severe acidosis, sepsis, SIRS)
  • pregnancy or lactation period (pregnancy testing will be executed on the ward at least one day prior to the surgical procedure)
  • edema, hypertonic dehydratation, hyperhidratation
  • hyperphosphatemia, hypernatremia,hypocalcemia
  • known hypersensitivity against IMPs and/or other components
  • known history or active abuse of alcohol and/or drugs

研究者

发起方
niversity Hospital Munich, Germany

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