DRKS00003355已完成未知
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
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