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临床试验/NCT01859260
NCT01859260撤回不适用

Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease

University of South Florida2 个研究点 分布在 1 个国家开始时间: 2013年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incidence of acute kidney injury

研究概览

简要总结

Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA is associated with worsening kidney function. Hospitalized patients are often exposed to multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which place them at risk for acute worsening of kidney function. This study aims to determine whether immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence of acute kidney injury during hospitalization. The investigators will evaluate the extent to which this effect can be attributed to a decrease in nocturnal hypoxia and improved blood pressure control. Secondary endpoints include hospital length of stay, and a composite outcome comprised of hemodialysis initiation, major cardiovascular events, and mortality.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CKD defined by National Kidney Foundation Staging system: eGFR < 60
  • Overnight sleep study consistent with OSA

排除标准

  • Currently treated with positive airway pressure for sleep-disordered breathing
  • Hemodynamically unstable, defined as SBP < 90, or use of vasopressors
  • Intubated or mechanically ventilated
  • Respiratory insufficiency, defined as P/F ratio < 250, or requiring mechanical ventilation
  • End stage renal disease on renal replacement therapy
  • Contraindication to CPAP, including active emesis, recent intracranial surgery, altered level of consciousness

结局指标

主要结局

Incidence of acute kidney injury

时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 days

incidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)

次要结局

  • Nocturnal hypoxia(participants will be followed for the duration of hospital stay, an expected average of 5 days)
  • composite outcome(participants will be followed for the duration of hospital stay, an expected average of 5 days)
  • Hospital length of stay(participants will be followed for the duration of hospital stay, an expected average of 5 days)
  • Blood pressure control(participants will be followed for the duration of hospital stay, an expected average of 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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