Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 14
- 主要终点
- Occurence of contrast-induced nephropathy
研究概览
简要总结
The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.
详细描述
The Strength Trial is a randomized, international (France and Germany) and multicentre (7) trial.
The patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..
This is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.
Standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume.
The patients are randomized to be protected from contrast-induced nephropathy with the use of RenalGuard or by standard hydration treatment and will be followed-up during 12 months.
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
- 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
- •Age > 18 years old
- •15 ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2
- •High volume contrast-requiring cardiovascular procedures (estimated contrast volume > 3 times eGFR value)
- •Patient has agreed to all FU testing
排除标准
- •Administration of iodine contrast media within 5 days before index procedure
- •Emergency procedure or primary PCI
- •Patients with pulmonary edema or cardiogenic shock (Killip 3 or 4)
- •Hypoxemia defined as SaO2 ≤ 90% and/or PaO2 ≤ 80 mmHg on room air
- •Acute Kidney Injury requiring dialysis before the procedure
- •Multiple myeloma or cancer treated with chemotherapy
- •Subjet is anuric
- •Subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month
- •Known hypersensitivity to furosemide active ingredient or excipient
- •Renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances
- •Pre-coma or coma induced by an hepatic encephalopathy
- •Severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration
- •Hypersensitivity to sulfamides
- •Enrollment in another study unless the study is a registry or unless primary endpoint is reached
- •Expected life expectancy < 1 year
- •Pregnant or breastfeeding patient
- •Patient under trusteeship or guardianship
- •Patient is unable / unwilling to provide an informed consent
结局指标
主要结局
Occurence of contrast-induced nephropathy
时间窗: Within 5 days
The occurence of contrast-induced nephropathy will be determined: * by an elevation, within 3 days from requiring contrast-procedure, of the serum creatinine (rise of 0.3mg/dl or of 25% compared to basal value) and/or * by the need for dialysis within 5 fays from requiring contrast-procedure
次要结局
- Change in serum creatinin value(at 12 +-1 months)
- Change in the estimated glomerular filtration rate(at 12 +-1 months)
- Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines(Index hospitalization (including staged procedures) and 12+- 1 months)
- Percentage of patients on chronic dialysis(at 12 +-1 months)
- Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)(at 12 +-1 months)
- Percentage of patients on temporary dialysis(at 12 +-1 months)
- In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter(within 5 days from procedure)
- Individual MACCEs components (death, myocardial infarction, stroke, revascularization)(at 12 +-1 months)