Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 592
- 试验地点
- 1
- 主要终点
- The association between plasma aging biomakers and contrast induced nephropathy
研究概览
简要总结
Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results. The investigators explored the association between plasma aging biomakers such as sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.
详细描述
Acute kidney injury represents an important clinical problem in hospitalized patients, with persistently high rates of mortality and morbidity. With an ever-increasing number of patients receiving intravascular injection of iodinated contrast media worldwide, contrast induced nephropathy (CIN) has become the third leading cause of hospital-acquired AKI. Approximately half of these cases are in patients undergoing cardiac catheterization procedures.
The prevention and early intervention of CIN has been hampered mainly by the lack of a consensus definition and the paucity of early predictive biomarkers to accurately identify high-risk patients. CIN is most frequently defined as an increase in serum creatinine (sCr) by 25-50% above the baseline, generally occurring within the first 24 h after contrast exposure, in the absence of other causes. However, sCr is an unreliable indicator during acute changes in kidney function, and alterations in sCr levels are not particularly sensitive or specific for small changes in the glomerular filtration rate (GFR)e, gender, race and intravascular volume. Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients aged 18 years or older undergoing planed PCI were prospectively recruited
排除标准
- •Pregnancy
- •Lactation
- •The intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1)
- •Nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days
- •A history of serious allergic to contrast media
- •Renal transplantation
- •End-stage renal disease necessitating dialysis
- •Severe concomitant disease of other systems.
研究组 & 干预措施
CIN proup
The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure.
干预措施: contrast (Drug)
control group
The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure.
干预措施: contrast (Drug)
结局指标
主要结局
The association between plasma aging biomakers and contrast induced nephropathy
时间窗: 48-72 hours
The plasma concentrations human soluble a-Klotho levels were measured by Enzyme Linked Immunosorbent Assay (ELISA) (Immuno-Biologic Laboratories Co., Ltd. Japan). This novel method detects sklotho using a monoclonal antibody with high affinity to the human a-Klotho protein.Hs-CRP was tested with a Beckman Coulter Immage immunobiochemistry system (USA) using nephelometry (unit: mg/L). Creatinine clearance (CrCl) was calculated by applying the Cockcroft- Gault formula to the serum creatinine concentration.
次要结局
- The association between plasma aging biomakers and in-hospital MACE in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.(30 days, 1 year)
研究者
Xiao-dong Zhuang
department of cardiology, first affiliated hoapital of SYSU
Sun Yat-sen University