Phase 4 Study of Effect of a Pre-interventional Calorie Restriction on Renal Function After Administration of Contrast Agent in Patients at Risk
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)
研究概览
简要总结
The aim of this study is to assess the effect of a diet prior to administration of contrast agent in terms of a preventive procedure which leads to an attenuation of the contrast-induced nephropathy (CIN).
Patients with a known kidney disease are especially at risk. A potential beneficial effect of a diet prior to intervention has been shown in investigations in mammals, therefore this study will investigate if a pre-interventional diet in patients with known kidney disease and scheduled contrast agent examination can attenuate or prevent a post-interventional loss of kidney function.
详细描述
Patients with contrast agent examinations are at risk for contrast-induced nephropathy (CIN) and in succession acute renal failure which is associated with significant morbidity and mortality. None of the currently used preventive procedures show a benefit in terms of a CIN-prevention.
Experimental data suggests, that a pre-interventional caloric restriction might provide kidney protection in this context. This clinical trial investigates if this phenomenon is also applicable in humans. Patients with increased risk for a post-interventional 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 -4 until day -1 (included) pre-intervention (day 0 corresponds to day of intervention). Patients of the control group receive alimentation ad libitum.
Primary objective is the increase of serum creatinine in mg/dl 48 h after begin of intervention in comparison to baseline value obtained in the morning of the day of intervention (day 0) in order to analyse if a pre-interventional calorie restriction as a preventive strategy leads to an attenuation of post-interventioal kidney injury.
Hypothesis
A four day calorie restriction reduces the increase of serum creatinine after administration of contrast agent 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 coronary angiography
- •indication for coronary angiography is determined by the referring physician
- •Patient and/or legal guardian must be willing and able to give written informed consent
- •at least one of the following risk factors:
- •serum creatinine > 1,1 mg/dl in male patients or serum creatinin > 0,9 mg/dl in female patients
- •Type 2 diabetes
- •peripher arteriovascular disease
- •heartfailure with NYHA 3-4 or ejection fraction ≤ 50%
- •age over 70 years
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, < 51 kg in female
- •BMI > 35 kg/m2 or body weight > 120 kg
- •diet within the previous 4 weeks
- •Inappetence
- •Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics
- •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 Group
Patients who don't follow a special diet.
Diet Group
Patients who subsist on a special diet.
干预措施: Diet (Dietary Supplement)
结局指标
主要结局
Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)
时间窗: Baseline to 48 hours
次要结局
- Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.(Baseline to 24 hours)
- Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.(Baseline to 24 hours)
- Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.(Baseline to 24 hours)