Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- The Increase of serum creatinine in mg/dl 24 h after induction of ischemia ("cross clamping") in comparison to baseline value obtained in the morning of the day of surgery (day 0).
研究概览
简要总结
The aim of this study is to assess the effect of a diet prior to cardiac surgery on the common postoperative decline of renal function. Until now, there is no known drug or procedure to preserve the kidneys from this impairment. Patients with a known kidney disease are especially at risk. A potential beneficial effect of a diet prior to surgery has been shown in investigations in mammals, therefore this study will investigate if a preoperative diet in patients with known kidney disease and scheduled heart surgery can attenuate or prevent a postoperative loss of kidney function.
详细描述
Patients with cardiothoracic surgery are at risk for postoperative acute renal failure which is associated with significant morbidity and mortality. There is no drug or procedure known to prevent this loss of renal function. Experimental data suggests, that a preoperative caloric restriction might provide kidney protection in this context. This clinical trial investigates if this phenomenon is also applicable in humans. Patients with a increased risk for a postoperative renal failure due to known chronic kidney disease are randomized in 2 groups. Patients of the diet group receive a calorie restriction to 60% of the calculated daily energy rate from day -7 until day -1 (included) pre-surgery (day 0 corresponds to day of surgery). Patients of the control group receive alimentation ad libitum.
Primary objective is the increase of serum creatinine in mg/dl 24 h after induction of ischemia ("cross clamping") in comparison to baseline value obtained in the morning of the day of surgery (day 0) in order to analyse if a preoperative calorie restriction as a preventive strategy leads to a attenuation of postoperative kidney injury. Hypothesis: A seven day calorie restriction reduces the increase of serum creatinine after cardiac surgery in patients with known chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years of age or older
- •Caucasian origin
- •Scheduled cardiothoracic operation with employment of cardio-pulmonary bypass and a lead time of 11 days minimum.
- •Indication for cardiac surgery is determined by the cardiothoracic specialist
- •Patient and/or legal guardian must be willing and able to give written informed consent
- •one of the following risk factors:
- •serum creatinine >1,1 mg/dl in male and > 0,9 mg/dl in female
- •type 2 diabetes
- •peripheral artery occlusive disease
- •heart failure with NYHA III-IV (ejection fraction < 50 %)
- •combined CABG and heart valve surgery
- •further surgery after CABG or heart valve surgery
排除标准
- •End-stage renal disease (patient on dialysis)
- •Indwelling kidney transplant
- •Malnutrition (BMI < 18,5 kg/m2)
- •Body weight < 46 kg in male and < 51 kg in female
- •BMI > 35 kg/m2 or body weight > 120 kg
- •Catabolic state (serum albumine < 25 g/l)
- •Diet within the previous 4 weeks
- •Inappetence
- •Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics
- •Hospital stay during the last 7 days prior to cardiac surgery
- •Consuming underlying disease
- •Uncontrolled local or systemic infection
- •Contraindication for enteral nutrition.
- •Known allergy against or incompatibility with ingredients of the employed formula-diet
- •Pregnancy or breast feeding
- •Participation in other interventional clinical trials.
- •Missing safe method of contraception or missing occurence of menopause (in female)
- •Professional or private relationship between subject and the investigators or dependence on the investigators.
- •Placement in an institution based on official orders.
研究组 & 干预措施
control
Ad libitum alimentation
calorie restriction
Calorie Restriction to 60% of the calculated daily energy rate from day -7 until day -1 (included) pre-surgery day 0 corresponds to day of surgery)
干预措施: calorie restriction (Other)
结局指标
主要结局
The Increase of serum creatinine in mg/dl 24 h after induction of ischemia ("cross clamping") in comparison to baseline value obtained in the morning of the day of surgery (day 0).
时间窗: baseline and 24 hours after induction of ischemia
次要结局
- Creatinkinase (CK) 24h after induction of ischemia(baseline and 24 h after induction of ischemia)
- Troponin T 24h after induction of ischemia(baseline and 24 h after induction of ischemia)
- Lactate dehydrogenase 24h after induction of ischemia(baseline and 24 h after ischemia)
- N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia(baseline and 24 h after ischemia)
- Necessity of renal replacement therapy during hospital stay(pt will be followed for the duration of hospital stay, an expected average of 10 days)
- Time until fit for discharge(Participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively(baseline and postoperatively, expected within 10 days after operation)
- Leucocyte count 24h after induction of ischemia(baseline and 24h after induction of ischemia)
- Occurrence of acute renal failure in accordance with KDIGO I, II, III(Patients will be followed during hospital stay, an expected average of 10 days)
- Urine Neutrophil-Gelatinase associated Lipocalin (NGAL in µg/l) 8h after induction of ischemia in comparison to baseline value obtained in the morning of the day of surgery (day 0).(baseline and 8 hours after induction of ischemia)
- Maximum increase of serum creatinine within the first 48 h after induction of ischemia(baseline and 48 hours after ischemia)
- C-reactive Protein (CRP) 24h after induction of ischemia(baseline and 24 h after induction of ischemia)
- Serum lactate 24h after induction of ischemia(baseline and 24 hours after ischemia)
- Length of hospital stay(Pt will be followed for the duration of hospital stay an expected average of 10 days)
- In-hospital mortality(pt will be followed for the duration of hospital stay, an expected average of 10 days)