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临床试验/NCT06223594
NCT06223594已完成不适用

Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Methodist Health System1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Rate of fluid overload

研究概览

简要总结

Acute pancreatitis (AP) is a common disease of the gastrointestinal tract that can result in emotional, physical, and financial burdens on the patient.

详细描述

In the last 20 years, the incidence of AP and rate of hospitalization have steadily increased. Approximately, two-thirds of AP patients will have a mild and self-limiting course of the disease, leaving the remaining one-third experiencing moderately severe to severe disease that is associated with worse outcomes. Overall, the estimated mortality of pancreatitis is 1% however, mortality can be as high as 30% to 40% among patients with AP and organ failure or pancreatic necrosis. Despite numerous randomized clinical trials, there is no medication shown to be successful at treating AP.

AP is associated with fluid deficit secondary to low intake and vomiting. Early intravenous fluid (IVF) resuscitation has been long-established as the initial cornerstone treatment to prevent hypovolemia and subsequent organ failure within the first 48 to 72 hours. The rationale for such intervention is to provide adequate intravascular volume support to counteract fluid shift into the third space. However, available evidence for an effective fluid regimen is lacking with regard to the type of fluid, the optimal rate of administration, and how to assess appropriate goals/targets for adequate resuscitation. Furthermore, the literature has presented conflicting results on whether aggressive versus goal-directed fluid resuscitation will lead to a reduction in mortality and improve outcomes. Although early supportive care with IVF therapy is recommended by the major guidelines, there are potential, serious complications associated with aggressive resuscitation, including volume overload, respiratory failures, intra-abdominal compartments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ● Age > 18 years
  • Diagnosis of AP based on International Statistical Classification of Diseases( ICD)-10 code

排除标准

  • ● Diagnosis of chronic pancreatitis
  • Patients who did not follow the IVF infusion protocol
  • Received < 24 hours of IVF therapy
  • Transferred from another institution

结局指标

主要结局

Rate of fluid overload

时间窗: 72 hours

Rate of fluid overload at 72 hours, which is the absence of acute respiratory distress syndrome.

次要结局

  • number of Effective outcomes(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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