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临床试验/NCT03216577
NCT03216577已完成不适用

Short and Long-term Outcomes of Purpura Fulminans in Adults

Henri Mondor University Hospital26 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
26
主要终点
Rate of amputation in the hospital;

研究概览

简要总结

Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the association of a sudden and extensive purpura together with acute circulatory failure. The mortality of PF has been reported to be as high as 50% in previous adult series. Additionally, patients surviving to the early phase of PF are exposed to a high risk of limb amputation. The hOPeFUL study aims at assessing the short and long term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans.

详细描述

Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the association of a sudden and extensive purpura together with acute circulatory failure. Neisseria meningitidis and Streptococcus pneumoniae are the most frequently involved microorganisms but other species (e.g., Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae...) have also been reported. Despite prompt antibiotics administration and intensive care management, the mortality of PF has been reported to be as high as 50% in previous adult series. Additionally, patients surviving to the early phase of PF are exposed to a high risk of serious sequelae related to extensive skin necrosis and acral symmetrical gangrene, which typically requires limb amputations, a potential source of severe handicap in these previously young and healthy patients. Although the clinical features and outcomes of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections. The current study aims at assessing the short and long-term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans. A large multicenter retrospective cohort will be built in order to assess hospital outcomes (i.e., mortality and amputations). Long-term outcomes, including health-related quality variables, will be prospectively assessed among survivors and compared to septic controls (i.e., patients having septic shock non-related to purpura fulminans).

研究设计

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

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

  • •Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans and discharged alive

排除标准

  • •Age < 18 years
  • •Non infectious purpura
  • •Infective endocarditis

结局指标

主要结局

Rate of amputation in the hospital;

时间窗: day 60

factors associated with rate of amputation in the hospital (and hospital mortality) will be identified using a polytomous logistic regression model

Hospital mortality

时间窗: day 60

factors associated with hospital mortality (and rate of amputation in the hospital) will be identified using a polytomous logistic regression model

Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire

时间窗: Within 6 years of hospital discharge

This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

次要结局

  • Physical dimension scale of the SF-36 questionnaire(Within 6 years of hospital discharge)
  • Impact of Event Scale(Within 6 years of hospital discharge)
  • Mental component score of the SF-36 score(Within 6 years of hospital discharge)
  • Activity of daily living (ADL score)(Within 6 years of hospital discharge)
  • Hospital anxiety and depression scale(Within 6 years of hospital discharge)

研究者

发起方
Henri Mondor University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas de Prost

MD, PhD

Henri Mondor University Hospital

研究点 (26)

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