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临床试验/NCT04840225
NCT04840225已完成不适用

Anæmi Hos Patienter Med infektiøs Endokarditis - Karakteristik og Mekanismer (ANIE)

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2021年3月22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
209
试验地点
1
主要终点
Prevalence of anemia during hospitalization

研究概览

简要总结

Prospective study of prevalence and deep charecterization of anemia in patients with endocarditis from diagnosis undtill 6 months after discharge.

详细描述

Anemia is an adverse prognostic marker in both cardiac diseases and infectious diseases. In patients with bacterial endocarditis (IE), anemia has a prevalence of 55-80%. In a sub-study to our POET I trial (RCT with 400 patients with IE, published in NEJM 2019), preliminary data show a 5-fold increased risk of death within 6 months and 2-fold increased risk after 3 years, in non-surgically treated patients with hemoglobin <6.2mmol/L, compared to patients with no or mild anemia. Intensified treatment of anemia through e.g. intravenous iron infusions, in combination with erythrocyte stimulating agents or new treatments for anemia of inflammation, such as IL-6 inhibitors, could possibly improve outcome for patients with IE.

This study - ANIE - is a prospective study, aiming at further deep-characterizing of anemia in patients with IE, and associated outcomes. Degree of anemia of inflammation (AI) and iron-deficiency anemia during hospitalization and time to recovery will be assessed. Blood samples from 100 patients with IE will be collected during hospitalization and 3 months after discharge, i.e. also during expected recovery. Samples will be analyzed for standard markers of anemia and inflammation, as well as novel biomarkers for AI, such as IL-6, soluble transferrin receptor, erythroferrone and hepcidin. The sample size calculation is based on the assumption that the prevalence of AI is 50%, with a confidence interval of 95% and a margin of error of <10%. Comparisons will be made to patients with other infections and patients with pure inflammation (TAVI and TEVAR patients) and healthy blood donors.

ANIE is expected to give us an unprecedented insight into disease processes, stages and possible therapeutic targets for anemia in patients with IE.

The results will serve for designing the clinical trial of novel interventions to treat anemia in patients with IE, as a novel means to improve the outcome and reduce the high mortality in these patients.

Anemia is an adverse prognostic marker in both cardiac diseases and infectious diseases. In patients with bacterial endocarditis (IE), anemia has a prevalence of 55-80%. In a sub-study to our POET I trial (RCT with 400 patients with IE, published in NEJM 2019), preliminary data show a 5-fold increased risk of death within 6 months and 2-fold increased risk after 3 years, in non-surgically treated patients with hemoglobin <6.2mmol/L, compared to patients with no or mild anemia. Intensified treatment of anemia through e.g. intravenous iron infusions, in combination with erythrocyte stimulating agents or new treatments for anemia of inflammation, such as IL-6 inhibitors, could possibly improve outcome for patients with IE.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Infectious endocarditis, defined by Duke criteria

排除标准

  • Known rheumatic disease or immune defect
  • TAVI/TEVAR patients:
  • Inclusion Criteria:
  • Scheduled for a TAVI/TEVAR procedure
  • Exclusion criteria:
  • Clinical suspicion of infection
  • Known rheumatic disease or immune defect
  • Bacterial patients without IE (short infection):
  • Inclusion criteria
  • Patients admitted with an infection with gram positive bacteria, without IE Exclusion criteria
  • Known rheumatic disease or immune defect
  • Blood donors:
  • Exclusion criteria:
  • Antibiotic treatment within the last 2 months
  • Cancer, rheumatic disease or other known inflammatory disease
  • Surgery within the last 3 months
  • Pregnancy

结局指标

主要结局

Prevalence of anemia during hospitalization

时间窗: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)

Diagnosis of anemia through WHO/NCI criteria for anemia and severity of anemia at time of diagnosis, 1-4 weeks after initiation of relevant treatment and up to 6 months after discharge

次要结局

  • Prevalence of anemia due to inflammation in patients with IE and relevant controls(From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion))
  • Prevalence of iron deficiency anemia in patients with IE and relevant controls(From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion))
  • Time untill resolution of inflammation and anemia in patients with IE and relevant controls(From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion))

研究者

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

Mia Pries-Heje

MD

Rigshospitalet, Denmark

研究点 (1)

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