Aggressive Hydration in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to Prevent Contrast-Induced Nephropathy, A Randomized, Controlled Trial REduction of riSk of Contrast-Induced Nephropathy followINg carDiac Catheterization 1
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Contrast Induced Acute Kidney Injury
研究概览
简要总结
To compare the efficacy of 2 different hydration strategies, hydration according to clinical guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate hydration.
详细描述
all consecutive patients with STEMI，age at least 18 years, who were candidates for primary PCI at our institution were considered for enrollment in the present study. Initial exclusion criteria were contrast medium administration within the previous 14 days, end-stage renal failure requiring dialysis, and refusal to give informed consent. Eligible patients were randomly assigned in a 1:1 ratio to receive preprocedure and postprocedure hydration (adequate hydration group), hydration according to clinical guideline (guideline hydration group，control group )
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •all consecutive patients with STEMI, age at least 18 years, who were candidates for primary PCI were considered for enrollment.
排除标准
- •contrast medium administration within the previous 14 days or follow 72 hours,
- •end-stage renal failure or renal transplantation, and refuse PCI or dead during the procedure,
- •heart failure of cardiac shock or New York Heart Association class IV,
- •recent acute kidney injury defined as an absolute increase of 0.5 mg/dl in serum creatinine over baseline in the past 24h
- •,the presence of lactation, pregnancy,
- •malignant tumour or life expectancy less than 1 year,
- •allergy to contrast, peri-procedural receipt of metformin non-steroidalanti-inflammatory drugs in the past 48h and during the study period,
- •planned renal catheterization or heart valvular surgery。
研究组 & 干预措施
Guideline Hydration
No hydration for patients without chronic kidney disease(CrCl<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
干预措施: Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) (Drug)
Adequate Hydration
Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP <13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and >1.5 ml/kg/hr for LVEDP >18 mmHg, whereas,0.5 ml/kg/hr for LVEDP >20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
干预措施: 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) (Drug)
结局指标
主要结局
Contrast Induced Acute Kidney Injury
时间窗: 24 hours
defined as a greater than 10% or an absolute increase of 0.3mg/dl in serum Cystatin C over baseline during the first 24 h post-procedure.
Contrast-Induced Nephropathy
时间窗: 72 hours
defined as a greater than 25% or an absolute increase of 0.5 mg/dl in serum creatinine over baseline during the first 48- 72 h post-procedure
次要结局
- contrast-induced acute kidney injury(48 hours)
- Alteration of renal function(72 hours)
- Major adverse cardiovascular events(1 year)
- Composite contrast-induced acute kidney injury(48 hours)
- Persistent renal damage(3 months)
- Severe adverse renal events(1 year)
研究者
Jiyan Chen
MD
Guangdong Provincial People's Hospital