NCT00345501已完成2 期
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure
Onassis Cardiac Surgery Centre1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
研究概览
简要总结
The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in high-risk patients undergoing a coronary procedure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was <60 ml/min on their most recent sample drawn within 1 month of the planned procedure
排除标准
- •Circulatory shock for any reason, systolic blood pressure <95 mm Hg
- •Known acute renal failure
- •End-stage renal disease requiring dialysis
- •Intravascular administration of a contrast medium within the previous 10 days
- •Anticipated re-administration of contrast medium within the following 6 days
- •Inability to administer intravenous hydration at least 4 h before the procedure or study medication at least 30 min before the procedure
- •Primary intervention for acute infarction with ST elevation
- •A procedure performed within 2 h of acute hospital admission
研究组 & 干预措施
1
Experimental
Iloprost
干预措施: Iloprost (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
时间窗: 2-5 days after the procedure
or CMN is defined as a relative rise of at least 25% from baseline on the follow-up
时间窗: blood sample drawn at 2-5 days after the procedure
次要结局
- Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups(2-5 days after the procedure)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Prevention of Contrast Induced Nephropathy With Sodium BicarbonateAcute Kidney FailureNCT00472563Universidad de Antioquia212
已完成
2 期
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium BicarbonateRadiographic Contrast Agent NephropathyNCT00540904Barretos Cancer Hospital27
已完成
3 期
prevention of kidney injury caused by contrast media during angioplasty/graphy by adminstration of sodium potassium citrate solutiocontrast induced nephropathy.Drug- and heavy-metal-induced tubulo-interstitial and tubular conditionsIRCT2015050322065N1Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences190
撤回
不适用
Prevention guidelines for contrast-induced nephropathy in contrast-enhanced CT: Appropriate and cost-effective? The Amsterdam, Maastricht, Alkmaar, Contrast Induced Nephropathy-Guideline study (the AMACING study)acute renal failure10029149acute kidney injuryNL-OMON38644Academisch Medisch Centrum2,000
招募中
不适用
the Prevention of Contrast-Induced Nephropathy by Atrial Natriuretic Peptide in Endovascular Aneurysm Repair.patients underwent endovascular aneurysm repairJPRN-UMIN000003909Jikei University, School of Medicine Department of Surgery, Vascular Surgery50