Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Contrast induced nephropathy incidence
研究概览
简要总结
This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.
详细描述
This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy, this preconditioning is administered through repeated insufflation of an arterial pressure cuff in one of the patient arms, which in theory liberates vasoactive mediators that prevents the ischemic damage to the kidneys secondary to contrast media. All of the patients will receive endovenous normal saline to prevent nephropathy, which is a common strategy in our institution. Half of the patients will receive remote ischemic preconditioning while the other half will only receive a dummy preconditioning intended to keep the double blind strategy of the trial.
The main endpoint will be to ascertain the incidence of contrast induced nephropathy in both arms of the study, as a way to evaluate the efficacy of this strategy.
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
- 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
- •Hospitalized in general wards, emergency room or ambulatory consult.
- •18 years or older.
- •Requires computerized tomography with endovenous contrast.
- •Glomerular filtration rate between 30 - 60 mL/minute/1,73 m
- •Patient accepts and signs informed consent.
排除标准
- •Allergic to contrast media.
- •Unable to accept or sign informed consent.
- •Did not received endovenous saline before and/or after the contrast procedure.
- •Peripheral arterial disease.
- •Bilateral upper extremities lymph node dissection or any situation impending arterial pressure taking.
- •Morbid obesity (body mass index 40 or more).
- •Arterial systolic pressure greater than 175 mmHg.
研究组 & 干预措施
Real ischemic preconditioning
Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 50 mmHg above the systolic arterial pressure of the patient.
干预措施: Ischemic preconditioning (Procedure)
Real ischemic preconditioning
Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 50 mmHg above the systolic arterial pressure of the patient.
干预措施: Endovenous normal saline (Drug)
Dummy ischemic preconditioning
Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 10 mmHg above the diastolic arterial pressure of the patient.
干预措施: Endovenous normal saline (Drug)
结局指标
主要结局
Contrast induced nephropathy incidence
时间窗: 48 to 72 hours
Increase in serum creatinine by 0,3 mg/dL compared to initial values.
次要结局
- Adverse effects to preconditioning.(0 to 72 hours.)
研究者
Camilo Andrés Páez Angarita
Internal Medicine Resident
Fundacion Clinica Valle del Lili