CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,177
- 试验地点
- 54
- 主要终点
- Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.
研究概览
简要总结
The purpose of this research study is to compare the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine (NAC) with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients.
详细描述
The intravascular administration of iodinated contrast media for diagnostic imaging is a common cause of acute kidney injury (AKI) and a leading cause of iatrogenic renal disease. Contrast-induced AKI is associated with serious adverse outcomes including death, need for dialysis, prolonged hospitalization, and acceleration in the rate of progression of underlying chronic kidney disease. The benefit of IV isotonic bicarbonate compared to IV isotonic saline and of N-acetylcysteine for the prevention of contrast-induced AKI and associated adverse outcomes remains unclear. The purpose of this trial is to compare the effectiveness of IV isotonic sodium bicarbonate with IV isotonic sodium chloride and oral NAC with placebo for the prevention of serious adverse outcomes in 7,680 high-risk patients scheduled to undergo coronary or non-coronary angiography. Using a 2 x 2 factorial design, patients will be randomized to receive: 1) either peri-procedural IV isotonic sodium bicarbonate or peri-procedural IV isotonic saline and 2) either oral NAC or oral placebo prior to and for 5 days following the angiographic procedure. The primary study endpoint is a composite outcome comprised of death, need for acute dialysis, or persistent decline in kidney function within 90 days following the index angiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media in which it is anticipated that there will be an interval of 3 hours between the identification of the indication for angiography and the time of the planned procedure.
- •Pre-angiography eGFR <60 ml/min/1.73 m2 with diabetes mellitus or pre-angiography eGFR <45 ml/min/1.73 m2 with or without diabetes mellitus
- •Ability to provide informed consent
排除标准
- •Stage 5 chronic kidney disease (CKD) (eGFR <15 mL/min/1.73 m2)
- •Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low efficiency dialysis (SLED)
- •Unstable baseline serum creatinine (SCr) (if known) at the time of angiography defined by an increase in SCr of 25% over the 3 days prior to angiography
- •Decompensated heart failure requiring any of the following therapies at the time of angiography:
- •IV milrinone, amrinone, dobutamine, or nesiritide
- •Isolated ultrafiltration therapy
- •Intra-aortic balloon pump
- •Emergent angiography procedures defined as an anticipated duration of <3 hours between the identification of the indication for angiography and the time of the planned procedure.
- •Receipt of intravascular iodinated contrast within the 5 days preceding angiography
- •Receipt of oral or IV NAC within the 48 hours preceding angiography
- •Known allergy to N-acetylcysteine (NAC)
- •Known anaphylactic allergy to iodinated contrast media
- •Age <18 years
- •Pregnancy
- •Ongoing participation in an unapproved concurrent interventional study
研究组 & 干预措施
Saline & oral placebo
IV isotonic saline and oral placebo drug capsule
干预措施: IV isotonic saline (Drug)
Saline & oral placebo
IV isotonic saline and oral placebo drug capsule
干预措施: Placebo (Drug)
Saline & oral N-acetylcysteine
IV isotonic saline and oral N-acetylcysteine drug capsule
干预措施: IV isotonic saline (Drug)
Saline & oral N-acetylcysteine
IV isotonic saline and oral N-acetylcysteine drug capsule
干预措施: N-acetylcysteine (Drug)
Bicarbonate & oral placebo
IV isotonic bicarbonate and oral placebo drug capsule
干预措施: IV isotonic bicarbonate (Drug)
Bicarbonate & oral placebo
IV isotonic bicarbonate and oral placebo drug capsule
干预措施: Placebo (Drug)
Bicarbonate & oral N-acetylcysteine
IV isotonic bicarbonate and oral N-acetylcysteine drug capsule
干预措施: IV isotonic bicarbonate (Drug)
Bicarbonate & oral N-acetylcysteine
IV isotonic bicarbonate and oral N-acetylcysteine drug capsule
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.
时间窗: Within 90 days following angiography
Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.
时间窗: Within 90 days following angiography
Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.
次要结局
未报告次要终点