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临床试验/NCT03558646
NCT03558646已完成不适用

Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU

Saint-Louis Hospital, Paris, France1 个研究点 分布在 1 个国家目标入组 739 人开始时间: 2017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
发起方
入组人数
739
试验地点
1
主要终点
in ICU mortality

研究概览

简要总结

In Europe, hydroxocobalamin (cyanokit) has been used for suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, the impact of hydroxocobalamin on outcome has never been thoroughly evaluated. While hydroxocobalamin has long been presented as being side-effect free, recent data suggest that in patients with severe burns, its use was associated with the occurrence of acute renal failure by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation.

详细描述

In Europe, hydroxocobalamin (cyanokit) is the antidote recommended by expert consensus in cases of suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, cyanokit has never been evaluated in this indication. Clinical data suggest that in patients with severe burns, its use is associated with the occurrence of acute kidney injury by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation. The results of this study should guide future research and advice on the benefit-risk ratio of hydroxocobalamin.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission in ICU with smoke inhalation diagnosed

排除标准

  • 未提供

结局指标

主要结局

in ICU mortality

时间窗: through study completion, an average of 1 year

mortality in ICU or at day 90

次要结局

  • in ICU acute kidney injury (based on the KDIGO definition)(through study completion, an average of 1 year)

研究者

发起方
Saint-Louis Hospital, Paris, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr François Dépret

Chef de clinique assistant of the surgical critical burn unit, Principal investigator

Saint-Louis Hospital, Paris, France

研究点 (1)

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