Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 596
- 试验地点
- 2
- 主要终点
- Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
研究概览
简要总结
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty
详细描述
randomized controlled trial
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient have indication for coronary angiography or angioplasty.
- •Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation.
- •Written informed consent.
排除标准
- •History of contrast allergy.
- •The patient had end-stage renal failure with the need for hemodialysis.
- •The patient take medications that affect the kidneys function within 48 hours before study.
- •The patient had acute kidney injury from any cause.
- •The patient was received contrast media within 2 weeks before study.
- •The patient had cardiac arrest or shock.
- •The patient had peripheral arterial disease (PAD)
- •Pregnancy
- •Refused to study
研究组 & 干预措施
RIPre + RIPost
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
干预措施: RIPre (Procedure)
RIPre + RIPost
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
干预措施: RIPost (Procedure)
RIPre + Sham
Intervention: RIPre 200 mmHg + Sham 10 mmHg
干预措施: RIPre (Procedure)
RIPre + Sham
Intervention: RIPre 200 mmHg + Sham 10 mmHg
干预措施: Sham-Post (Procedure)
Sham + RIPost
Intervention: Sham 10 mmHg + RIPost 200 mmHg
干预措施: RIPost (Procedure)
Sham + RIPost
Intervention: Sham 10 mmHg + RIPost 200 mmHg
干预措施: Sham-Pre (Procedure)
Sham + Sham
Intervention: Sham 10 mmHg + Sham 10 mmHg
干预措施: Sham-Pre (Procedure)
Sham + Sham
Intervention: Sham 10 mmHg + Sham 10 mmHg
干预措施: Sham-Post (Procedure)
结局指标
主要结局
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
时间窗: Within a period of 24 hours after contrast medium administration
次要结局
- Change in sCr and eGFR from baseline(Within a period of 24 hours after contrast medium administration)
- Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group(Within a period of 6 months after contrast medium administration)
- Incidence(%) of CI-AKI in differrent subgroups of patient characteristics(Within a period of 24 hours after contrast medium administration)
- Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost(Within a period of 24 hours after contrast medium administration)
- Incidence(%) of MACCE in patients with vs without RIPre and RIPost(Within a period of 6 months after contrast medium administration)
- Incidence(%) of MACCE in differrent subgroups of patient characteristics(Within a period of 6 months after contrast medium administration)
- Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI(Within a period of 6 months after contrast medium administration)
研究者
Col. Suthee Panichkul
Phramongkutklao College of Medicine and Hospital
Phramongkutklao College of Medicine and Hospital