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临床试验/NCT02155114
NCT02155114已完成不适用

Iron Homoeostasis in Inflammation: A Single Center Observational Cross-sectional Study

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2014年4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
472
试验地点
1
主要终点
Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation

研究概览

简要总结

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

详细描述

  • Background: Iron deficiency is frequently encountered in the elderly, after bleeding and in the context of neoplasia. Our 2013 pilot study showed that iron deficiency is a common problem in medical inpatients (13.7%) and that about 55% of these also showed signs of inflammation. The relevance of iron storage levels on clinical outcome in the presence of inflammation is conflicting. On the one hand, lack of iron prevents many viruses and bacteria, as well as other microorganisms, to reproduce and on the other hand the abundance of available iron stimulates hematopoiesis and reduces symptoms of iron deficiency.
  • Methodology: We plan to enroll 1000-1500 patients with laboratory signs of inflammation during a period of six months and to analyze iron specific laboratory parameters twice during hospital stay. Additional laboratory analyses are planned for a smaller sample to portray the processes in iron homeostasis during inflammation.
  • Significance: Contradicting evidence of forty and more years of scientific research backs current therapeutic practices in patients with inflammatory disease and iron deficiency. This study records prevalence of different iron storage states, mortality, morbidity and therapies in inflammatory states combined with iron deficiency and could very well be able to recommend a therapeutic regimen as well as limits for typically used laboratory parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Hospitalized patient in internal medicine (≥ 24h)
  • •Evidence of an inflammatory state, determined as a C reactive protein (CRP) value >5 mg/l
  • •Written informed consent

排除标准

  • •History of terminal renal insufficiency in terms of dialysis or use of erythropoiesis-stimulating agents
  • •Pregnancy
  • •History of allogeneic stem cell transplantation

结局指标

主要结局

Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation

时间窗: up to 8 days

次要结局

  • Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution(up to 8 days)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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