Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Contrast induced nephropathy
研究概览
简要总结
Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast induced nephropathy (CIN) has not yet been studied in these patients, and evidence on different strategies is urgently needed. The objective of this study is to evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride) hydration prior to TAVI in patients with CKD to prevent CIN.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided written informed consent.
- •Patient is undergoing TAVI.
- •Patient has an estimated GFR <60ml/min/1.73m2.
排除标准
- •Patient has end-stage kidney disease requiring dialysis.
- •Emergent TAVI (planned before next working day).
- •Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
- •Allergy to contrast agent.
- •Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
- •Need for continuous hydration therapy (e.g. sepsis).
- •Multiple myeloma.
- •Contra-indication to sodium bicarbonate.
研究组 & 干预措施
hypotone saline
0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR
干预措施: hypotone saline (Drug)
sodium bicarbonate
250ml 1.4% sodium bicarbonate 1 h before TAVR
干预措施: sodium bicarbonate (Drug)
结局指标
主要结局
Contrast induced nephropathy
时间窗: Day 3
CIN is defined as an increase in Scr \>0.5 mg/dL or 25% within 72 hours
Acute heart failure due to volume expansion
时间窗: Day 3
次要结局
- Composite of CIN or acute heart failure(Day 3)
- Maximal relative change in serum creatinine(Day 3)
- Acute kidney injury(Day 3)
- Need for dialysis(Day 30)
- Need for blood transfusions(Day 3 and Day 30)
- Number of blood transfusions(Day 3 and Day 30)
- Length of hospital stay(Day 30)
- Recovery of renal function in CIN patients(Day 30)
研究者
Jan van der Heyden
Principal Investigator
St. Antonius Hospital