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临床试验/NCT02316366
NCT02316366已完成不适用

Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes

Nationwide Children's Hospital0 个研究点目标入组 80 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Rate of Hospital Admission

研究概览

简要总结

The purpose of this study is to determine if warming the intravenous (IV) fluid given to patients with Sickle Cell Disease who are experiencing painful episodes known as Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV pain medications given, improve pain and improve global comfort.

详细描述

Vaso-occlusive crisis (VOC) is a common painful complication of Sickle Cell Disease and is the primary reason that these patients seek medical care in the acute care setting. This complication arises when blood vessels are obstructed by sickled red blood cells resulting in ischemic injury.

The standard management of these painful episodes comprises the administration of opioid analgesics, the infusion of intravenous (IV) fluids at room temperature and rest. These episodes often last five to seven days and many patients require inpatient management for continued administration of intravenous analgesics.

The public health impact of the disease is large as admissions frequently result in school or work absences and can be financially and emotionally taxing.

It is well established that exposure to cold precipitates VOC. For this reason, management of the pain of VOC in some centers includes the use of warming blankets as an adjunct for pain relief. It is conceptually appealing to conjecture that warm fluids might have similar salutary effects on VOC. This conjecture is bolstered by the physiologic effect of temperature on vascular tone. Specifically, it is well established that cold temperatures cause vasoconstriction whereas warm temperatures cause vasodilation. We expect that warmed fluids will similarly induce vasodilation, improving blood flow to vaso-occluded ischemic areas.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Vaso-occlusive Episode defined as a pain rating of 3 or above on the Wong-Baker FACES score in a child with an established diagnosis of sickle cell disease (SS, SC or S β Thalassemia)
  • 4-21 years of age

排除标准

  • fever (temperature greater than 38 degrees Celsius)
  • inability to complete FACES pain scale
  • evidence of acute chest syndrome clinically or radiographically
  • deemed by attending physician to be so ill as to need immediate hospital admission.

研究组 & 干预措施

Warm fluid

Experimental

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

干预措施: Astoflo Plus fluid warmer (Device)

Room temperature Fluid

No Intervention

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)

结局指标

主要结局

Rate of Hospital Admission

时间窗: 4 hours

After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.

次要结局

  • Amount of Narcotic Administered(4 hours)
  • Time to Disposition(4 hours)
  • Difference in Pain Score(4 hours)
  • Global Comfort(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Renee Quarrie

Attending

Nationwide Children's Hospital

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