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临床试验/DRKS00004361
DRKS00004361已完成4 期

Effect of a preinterventional calorie restriction on renal function after contrast agent exposition in patients at risk. - CR_KM

niversität zu Köln0 个研究点目标入组 80 人开始时间: 2013年4月23日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
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

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 diuretics;
  • 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.

研究者

发起方
niversität zu Köln

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