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临床试验/NCT02854943
NCT02854943已完成不适用

The Prognostic and Diagnostic Value of Ferritin in Critically Ill Patients With Special Focus on Underlying Hemophagocytic Lymphohistiocytosis

Gunnar Lachmann0 个研究点目标入组 2,623 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,623
主要终点
Mortality

研究概览

简要总结

Retrospective analysis of ferritin, outcome and HLH-criteria in critically ill patients.

详细描述

The study is a retrospective register study of critically ill patients from Charité - Universitätsmedizin Berlin during 2000 and 2016 that had at least one measurement of plasma ferritin. Outcome, underlying diagnoses and HLH-2004 criteria (Henter JI et al. 2007) will be analyzed and the HScore of these patients will be calculated (Fardet L et al. 2014). All recorded data of the specific admission term in ICU will be used for the analysis. No follow-up of the patients after discharge will be performed in this study. The study does not involve any randomization or any drug testing.

Update 2019: We expanded our database for the years until 2018 and also for the surgical and medical ICUs of the Charité - Universitätsmedizin Berlin (from 256 to 2623 patients).

Update 2022: A systematic literature search will be performed to find suitable validation cohorts for multicenter validation of optimized HLH diagnostic criteria, which are calculated based on our data (new secondary endpoint).

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
否

入选标准

  • •male and female patients
  • •at least one measurement of plasma ferritin

排除标准

  • •age below 18 years

结局指标

主要结局

Mortality

时间窗: Participants will be followed up for the duration of hospital stay, an expected average of two months

A retrospective analysis of patients with available charts to determine the outcome whether patients survived the ICU or died.

Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)

时间窗: The participants will be followed up for the duration of hospital stay, an expected average of two months

Retrospective analysis of available charts, underlying diagnoses, findings and blood values: HLH-2004 criteria (Henter JI et al. 2007) and HScore (Fardet L et al. 2014)

次要结局

  • Diagnoses(Participants will be followed up for the duration of hospital stay, an expected average of two months)
  • Intensive care unit stay(Participants will be followed up for the duration of intensive care unit stay, an expected average of one week)
  • Improving HLH diagnostic criteria including multicenter validation(Participants will be followed up for the duration of intensive care unit stay, an expected average of one week)

研究者

发起方
Gunnar Lachmann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gunnar Lachmann

Specialist in Anesthesiology of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Charite University, Berlin, Germany

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