Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- The primary endpoint will be change in the creatinine concentration between the 48-72 hours creatinine levels and the baseline levels, expressed as ratio.
研究概览
简要总结
The purpose of this study is to investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk patients.
详细描述
Rationale: Iodinated contrast media are regularly used in diagnostic and interventional procedures. The intravascular use of these contrast media can cause acute kidney injury (Contrast Induced Nephropathy). Contrast Induced Nephropathy is associated with increased morbidity and mortality. There are no treatment options, therefore preventive measures should be taken. Volume expansion reduces the risk of Contrast Induced Nephropathy. Current guidelines for the prevention of Contrast-Induced Nephropathy advise that high risk patients be admitted for hydration with intravenous normal saline for a period of 8-24 hours. This proposal evaluates an alternative method of hydration; home hydration with salt tablets.
Objective: To investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk patients.
Study design: multi-centre randomized controlled trial.
Study population: Adult patients > 18 years undergoing an elective procedure involving intravascular administration of iodinated contrast media and at high risk for the development of Contrast Induced Nephropathy (as defined by guideline criteria).
Intervention: Arm A: sodium chloride 1g/10kg of body weight/day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day.
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
- •Adult patients > 18 years undergoing an elective procedure involving intravascular administration of iodinated contrast media
- •high risk for the development of Contrast Induced Nephropathy (as defined by guideline criteria
排除标准
- •Low risk for the development of CIN, therefore no need for hydration
- •Emergency contrast procedure.
- •Overt signs of overhydration; orthopnea or pulmonal rales at the time of the first consult.
- •Double or triple diuretic use for pre-existing heart failure. Severe heart failure, in which case salt load is not safe (physician decision) Severe renal failure (CKD stage V eGFR < 15ml/min/1.73m2) Multiple Myeloma. Repeated contrast exposure < 2 weeks Unstable serum creatinine > 25% change < 6 weeks The inability to provide written informed consent. Participation in another intervention study
研究组 & 干预措施
Arm A: sodium chloride tablets
Arm A: sodium chloride 1g/10kg of body weight /day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day.
干预措施: Sodium chloride tablets (Drug)
B: isotonic saline intravenously
Sodium chloride solution (isotonic saline (NaCl 0.9%) total 1000ml in 4 hrs or (in case of heart failure or severe renal failure) 12 hrs before and in 4 or in 12 hrs after contrast administration.
干预措施: Isotonic saline intravenously (Drug)
结局指标
主要结局
The primary endpoint will be change in the creatinine concentration between the 48-72 hours creatinine levels and the baseline levels, expressed as ratio.
时间窗: 48-72 hours after contrast administration
次要结局
- we will evaluate the incidence of contrast nephropathy in the groups defined as a rise in serum creatinine of ≥25% or ≥44umol/L 48-72 hours after contrast administration(48-72 hours after contrast administration)
- the incidence of adverse events(up to 1 week after intervention)
- patient satisfaction.(up to 1 week after intervention)
研究者
Prof. Dr. J. Wetzels
Clinical Professor
Radboud University Medical Center