跳至主要内容
临床试验/EUCTR2007-000223-17-NL
EUCTR2007-000223-17-NL进行中(未招募)不适用

PRACDICAL StudyPrevention and Risk factors of Arterial Complications in DIabetics after non-CArdiac surgicaL interventions - PRACDICAL study

M.S. Arbous0 个研究点目标入组 2,000 人开始时间: 2007年8月29日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,000

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 with type 1 or type 2 diabetes undergoing elective non-cardiac surgery. Patients are either treated with oral hypoglycaemic agents, insulin or diet-restrictions.
  • - Age over 18 years
  • - male or female
  • - Able and willing to give informed consent
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients scheduled for surgery in day-care or emergency surgery
  • - Psychiatric or mentally challenged patients (or patients with other disorders who will have difficulty filling out the questionnaires)
  • - Patients with severe liver disease:
  • Criteria: Child Pugh B or C, or bilirubinuria, elevation of serum bilirubin (>35 mmol/L), elevated aminotransferase levels (>500 U/L), elevated alkaline phosphatase (>4 times normal values), albumin < 28, INR > 1.7
  • - Patients who do not speak Dutch or English
  • - Patients who are planned to be admitted postoperatively to the Intensive Care Unit (ICU) since in all ICUs a protocol on intensive glycaemic control is employed.

研究者

发起方
M.S. Arbous

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