EUCTR2012-003696-18-DE进行中（未招募）1 期
Effect of a preinterventional calorie restriction on renal function after contrast agent exposition in patients at risk. - CR_KM
niversity of Cologne0 个研究点开始时间: 2013年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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.men and women 18 years of age or older
- •2.caucasian origin
- •3.scheduled coronary angiography
- •4.indication for coronary angiography is determined by the referring physician
- •5.Patient and/or legal guardian must be willing and able to give written
- •informed consent
- •6.at least one of the following risk factors:
- •serumkreatinine > 1,1 mg/dl in male patients or serumkreatinin > 0,9 mg/dl in
- •female patients
- •Diabetes mellitus
- •peripher arteriovascular disease
- •heartfailure with NYHA 3-4 or ejection fraction = 50%
- •age over 70 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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1.End-stage renal disease (patient on dialysis);
- •2.Indwelling kidney transplant;
- •3.Malnutrition (BMI < 18,5 kg/m2);
- •4.Body weight < 46 kg in male, < 51 kg in female;
- •5.BMI > 35 kg/m2 or body weight > 120 kg;
- •6. diet within the previous 4 weeks;
- •7.Inappetence ;
- •8.Weight loss > 1 kg within the previous 2 weeks, if not explained by use of
- •09.Consuming underlying disease;
- •10.Uncontrolled local or systemic infection;
- •11.Contraindication for enteral nutrition;
- •12.Known allergy against or incompatibility with ingredients of the employed
- •formula-diet;
- •13.Pregnancy or breast feeding;
- •14.Participation in other interventional clinical trials;
- •15.Missing safe method of contraception or missing occurence of menopause
- •(in female);
- •16.Professional or private relationship between subject and the investigators
- •or dependence on the investigators;
- •17.Placement in an institution based on official orders.
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