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
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