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临床试验/NCT04071067
NCT04071067Unknown不适用

Anemia of Inflammation and Deficiency Anemia in Critically Ill Patients; Biological Markers

Iuliu Hatieganu University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
2
主要终点
Number of transfusions during ICU stay

研究概览

简要总结

Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Of the 783 patients included in the study, 551 (73.37%) had anemia on admission. Frequently anemia is present on discharge from ICU or hospital and may persist for an average of 11 weeks. Some studies have reported the presence of anemia as far as 6 months after discharge. It is widely accepted that anemia has a negative impact on rehabilitation and quality of life, but the treatment can not be exclusively based on blood products due to the risks associated with transfusion. Alternative treatments such as injectable iron or erythropoietin should be considered.

The Transfusion Management Initiative Group recently issued recommendations on perioperative anemia. Similar recommendations for ICU have not yet been developed in Romania. The current study has two main purposes. The first to adopt the perioperative anemia diagnostic algorithm and adapt it to anemic patients on ICU; the second to identify patients with mixed anemia (inflammatory and iron deficient anemia) who can benefit from treatment with iron.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients admitted to ICU
  • ICU stay >48hours

排除标准

  • Refusal to participate in the study
  • Allergy to iron products
  • Anemia requiring massive transfusion in the last 7 days
  • Treatment of iron products in the last 7 days
  • Chronic renal failure with GFR <30mL / min or on dialysis
  • Metabolism of iron
  • Pregnant or lactation patients
  • Rheumatic diseases
  • Inflammatory bowel diseases
  • Hematological pathologies
  • Impossibility of performing laboratory tests within 72 hours of admission

结局指标

主要结局

Number of transfusions during ICU stay

时间窗: Up to 3 months of hospital stay

Change in hemoglobin levels during ICU stay

时间窗: 21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;

次要结局

  • Days spent in hospital(Up to 3 months)
  • Number of hours of mechanical ventilation during hospital stay(Up to 3 months)
  • Days spent on ICU(Up to 3 months of hospital stay)
  • Change in hemoglobin level during hospital stay(Up to 3 months: week 3=point 1; week 6=point 2; week 9=point 3; week 12=point4)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Constantin Bodolea

Head of 2nd Anesthesia Department

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (2)

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