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临床试验/NCT02940171
NCT02940171终止不适用

Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2016年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
470
试验地点
2
主要终点
mortality

研究概览

简要总结

The prognostic of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain, however. In this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill burn patients using a propensity analysis.

详细描述

The first aim of the study is to explore the impact of timing of the first surgery on outcome of severely ill burn patients. Because a randomization would not be feasible in this setting, we will use a propensity analysis in matching patients receiving early surgery and those receiving late surgery. Secondary aims are to evaluate the impact of the timing of surgery on morbidity (organs failure, infections, sepsis) but also to assess the diagnostic and prognostic value of plasma and urine biomarkers in severely ill burn patients

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Age >18 years
  • Admission to a burn unit within 72 hours from a burn injury
  • Total burned surface area (TBSA)>20%(2nd degree or 3rd degree) for any type of burn
  • Patient covered by the social security
  • Non-opposition to participate to the study and to the constitution of the biological collection

排除标准

  • Decline to participate
  • Decision not to resuscitate order before surgery
  • Pregnant or breastfeeding patiente
  • Decision to limit therapies in the first 24 hours
  • Patient not resident in France
  • Patient deprived of liberty

结局指标

主要结局

mortality

时间窗: 90 days

次要结局

  • Organ failure(28 and 60 days)
  • Recovery from acute kidney(Until 28 and 60 days from burn injury)
  • Nosocomial infections (numbers) during first 60 days(First 60 days)
  • Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days(First 28 days)
  • Nosocomial sepsis during first 60 days(First 60 days)
  • Length of stay in the ICU(One year)
  • analog scale of quality of life(One year)
  • One year mortality(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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