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临床试验/NCT04214756
NCT04214756进行中(未招募)不适用

Methodist 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: 2014年4月5日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
1
主要终点
Discharge status

研究概览

简要总结

The overall goal of this ongoing registry study is to optimize initial evaluation and treatment of patients with AP according to recommended guidelines, the Methodist Acute Pancreatitis Protocol (MAPP), which were implemented in January 2015.

详细描述

1.1. Background

Acute pancreatitis (AP) represents a significant burden for patients, their caregivers, and our healthcare delivery systems. The most common discharge gastrointestinal diagnosis is AP and more than two billion dollars is spent annually for management thereof . Costs are certainly even higher as the incidence of AP has increased. Admit frequency for AP doubled in 15 years before 2002 such that more than 200,000 admissions were attributed to AP, and the trend toward increased admissions for AP has continued. Overall, about 20% of AP cases are severe and the risk for fatality attributed to severe AP is significant (> 25%). Classification of AP severity is defined into three groups: mild, moderately severe, and severe. These categories have been validated in that standard clinical outcomes correlate well with the severity of AP.

There are several principle gaps in knowledge with respect to AP. First, it remains challenging to initially predict the ultimate severity of acute pancreatitis . Some patients presenting with what is thought to be a mild attack of AP ultimately progress to having more severe disease. This is of utmost importance because outcomes of AP seem to be clearly related to very early diagnosis and appropriate initial management. For example, both morbidity and mortality for AP are closely related to persistent organ failure, which in theory might be prevented with very early appropriate management. It is also not clear if the existing data regarding prognostic scoring systems were influenced by early interventions. Secondly, we lack confirmatory data that following recommended guidelines for management of AP in fact results in improved clinical outcomes. It has been suggested that the care of AP patients has changed considerably during the last decade. One might assume that this change was in response to following one or all of several different guidelines produced by international societies. However, there is a paucity of outcomes data, particularly related to patients that have been cared for according to the recommended guidelines, and further investigation is warranted. Lastly, many AP studies include patients who had onset of symptoms more than several days prior to admission or transfer to a tertiary center; careful study is warranted in AP patients who present within one to two days of symptom onset.

The evaluation and treatment of all patients with AP according to specific guidelines embodies the principles of patient-centeredness research and improved clinical outcomes may also translate into better quality of life. Patients who suffer from severe AP that is complicated by pancreatic necrosis continue to have poor physical components of quality of life. However, the burden for patients with AP extends beyond the obvious clinical outcomes. Even as symptom scales from quality of life instruments improve following recovery, mental component scores remain significantly impaired.

1.2. AIMS/OBJECTIVES

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Age ≥ 18 years
  • Presented to ER with Acute severe pain for < 48 hours before presentation.
  • Laboratory values of Lipase and/or amylase > 3X normal

排除标准

  • History of recent penetrating or blunt abdominal trauma
  • Patients transferred to MDMC for upper abdominal pain consistent with pancreatic etiology

结局指标

主要结局

Discharge status

时间窗: From April 2016 until Jun 2025 (anticipated study close)

will be recorded as a categorical variable indicating whether the discharge was to the home, SNF or rehab facility (1=Home; 2 = SNF; 3 = Rehab)

Length of Hospital Stay

时间窗: From April 2016 until Jun 2025 (anticipated study close)

Length of hospital stay will be calculated in days with a discrete variable as \[(discharge date - Admission date)\].

Ward days

时间窗: From April 2016 until Jun 2025 (anticipated study close)

Length of ward days will be calculated in days with a discrete variable as \[(discharge date from ward - Admission date to the ward)\].

ICU days

时间窗: From April 2016 until Jun 2025 (anticipated study close)

Length of ICU stay will be calculated in days with a discrete variable as \[(discharge date from ICU - Admission date to the ICU)\].

次要结局

  • Harmless AP score (HAPS)(From April 2016 until Jun 2025 (anticipated study close))
  • C reactive protein(From April 2016 until Jun 2025 (anticipated study close))
  • Procalcitonin(From April 2016 until Jun 2025 (anticipated study close))
  • Empiric antibiotics(From April 2016 until Jun 2025 (anticipated study close))
  • bedside index for severity in AP (BISAP)(From April 2016 until Jun 2025 (anticipated study close))
  • Severity of acute pancreatitis (AP)(From April 2016 until Jun 2025 (anticipated study close))
  • CT scan(From April 2016 until Jun 2025 (anticipated study close))
  • organ dysfunction scores(From April 2016 until Jun 2025 (anticipated study close))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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