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临床试验/DRKS00003355
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Effect of a preoperative calorie restriction on renal function after cardiac surgery in patients at risk - CR_KCH

niversität zu Köln0 个研究点目标入组 82 人开始时间: 2011年11月23日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
82

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 over 18 years
  • 2.caucasian origin
  • 3.scheduled cardiothoracic operation with employment of cardio-pulmonary bypass and a lead time of 11 days minimum.
  • 4.indication for cardiac surgery is determined by the cardiothoracic specialist
  • 5.Patient and/or legal guardian must be willing and able to give written informed consent
  • 6.chronic renal impairment with serum creatinine > 1,5 mg/dl or creatinine > 1,1 mg/dl with at least one of the following risk factors:
  • a. Diabetes mellitus b. pAOD c. heart failure (EF < 50%)

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.catabolic state (serum albumine < 25 g/l)
  • 7.diet within the previous 4 weeks
  • 8.Inappetence
  • 9.Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics
  • 10.Hospital stay during the last 7 days prior to cardiac surgery
  • 11.Consuming underlying disease
  • 12.Uncontrolled local or systemic infection
  • 13.Contraindication for enteral nutrition.
  • 14.Known allergy against or incompatibility with ingredients of the employed formula-diet
  • 15.Pregnancy or breast feeding
  • 16.Participation in other interventional clinical trials.
  • 17.Missing safe method of contraception or missing occurence of menopause (in female)
  • 18.Professional or private relationship between subject and the investigators or dependence on the investigators.
  • 19.Placement in an institution based on official orders.

研究者

发起方
niversität zu Köln

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