A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia With the Use of Standard Laboratory Measures and Novel Biomarkers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
研究概览
简要总结
The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function.
Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.
Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72 hours after the procedure
详细描述
Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion The first group of patients receives standard peroral hydration of 1500 ml water on the day of the procedure.
The second group receives 3 mL/kg/hour of Na bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography.
The third group receives parenteral NAC (1200 mg twice a day) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Na bicarbonate solution on the day of the angiography.
The low-osmolar iodinated contrast agent was used.
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
- Single (Investigator)
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
- •angina (stable, unstable)
- •coronary artery disease
- •cardiomyopathy
- •valvular disease
- •vasculitis
- •peripheral arterial disease
排除标准
- •kidney dysfunction
- •uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg)
- •pregnancy
- •lactation
- •history of allergic reaction to contrast agents
- •cardiogenic shock
- •pulmonary edema
- •multiple myeloma
- •urgent coronary angiography
- •receiving contrast agents two days prior to the study and 48 hours within the study
研究组 & 干预措施
Sodium bicarbonate
3 mL/kg/hour IV (in vein) of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
干预措施: Sodium bicarbonate (Drug)
N-acetylcysteine plus Sodium bicarbonate
N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Sodium bicarbonate solution on the day of the angiography.
干预措施: Sodium bicarbonate (Drug)
N-acetylcysteine plus Sodium bicarbonate
N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Sodium bicarbonate solution on the day of the angiography.
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
时间窗: 48 hours
measure of serum creatinine before and after diagnostic procedure
次要结局
- blood urea nitrogen in mmol/L(48 hours)
- neutrophil gelatinase-associated lipocalin in ng/mL(48 hours)
研究者
Ana Vujaklija Brajkovic
M.D. PhD
Clinical Hospital Centre Zagreb