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临床试验/NCT03204669
NCT03204669已完成不适用

Trace Element Repletion Following Severe Burn Injury

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 1999年6月1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
139
试验地点
1
主要终点
Trace elements plasma concentration

研究概览

简要总结

Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace element (TE) repletion has been shown to improve clinical outcome. The study aimed to check if our repletion protocols were achieving normalization of TE plasma concentrations of major burn patients and if the necessity for continuous renal replacement therapy (CRRT) might increase the needs.

详细描述

Retrospective analysis of prospectively collected data in burn patients requiring intensive care (ICU) between 1999 and 2015. The cohort was divided into 4 groups according to the protocol changes. Period 1 (P1): 1999-2000, P2: 2001-2005, P3: 2006-2010, P4: 2011-2015. Changes consisted mainly in increasing TE repletion doses and duration. Demographic data, daily TE intakes and weekly plasma concentrations were retrieved for the first 21 ICU-days.

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
14 Years 至 86 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Burn injury involving ≥20% body surface (TBSA) (i.e. the threshold for intravenous TE repletion prescription)
  • At least one TE plasma concentration during the ICU stay

排除标准

  • Comfort care
  • Admission >24h after burn injury

结局指标

主要结局

Trace elements plasma concentration

时间窗: 21 days

Copper, Selenium and Zinc plasma concentrations, measured by inductively coupled plasma mass spectrometry (ICP-MS). The recommendation was to check them on a weekly basis.

次要结局

  • Number of infectious complications(21 days)
  • Length of mechanical ventilation(Up to 120 days)
  • Length of stay(Up to 250 days)

研究者

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

Mette M Berger

Prof

Centre Hospitalier Universitaire Vaudois

研究点 (1)

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