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临床试验/NCT05693194
NCT05693194招募中不适用

Prevalence of Anemia in PICU Survivors: Epidemiology, Pathophysiology and Consequences

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Prevalence of anemia at 2 months post PICU discharge

研究概览

简要总结

In 2007, the TRIPICU trial which demonstrated the safety of tolerating anemia in critically ill children through avoidance of unnecessary red cell transfusions. This landmark study led to practice changes and a reduction in the use of red cell transfusion during PICU stay. However, although this restrictive approach appears safe in the acute setting of PICU, there is a paucity of data regarding its long-term impact on the burden of anemia at discharge. Although 98% of patients now survive their PICU stay, we and other groups have documented that around 50% of PICU admissions will be anemic at discharge. A major contributing factor may be the increasing adoption of restrictive red cell transfusion policies during the phase of ICU admission. Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children are discharged with anemia.

The causes of anemia are multifactorial, including inflammation, co-morbidities and nutritional, including iron depletion. Anemia, in particular iron deficiency anemia, is well recognized to be associated with abnormal neurocognitive development in infants and young children. Anemia can also contribute to lower exercise tolerance levels impeding children's development and quality of life.

This protocol describes a prospective observational cohort study of PICU survivors, to better understand the epidemiology of anemia at and after PICU discharge. The primary aim will be to determine the prevalence of anemia at 2 months after PICU discharge (primary aim) as well as at 6 and 12 months follow-up (secondary aim). We will evaluate the association of anemia with neurocognitive dysfunction, and quality of life (secondary aim). We will also investigate the pathophysiology of anemia after PICU discharge. We will perform blood tests on anemic patients to measure inflammatory markers as well as markers of iron deficiency (including the new biomarker hepcidin) (tertiary aim).All patients included will be followed while hospitalized in the PICU, as well as at dedicated clinics at 2, 6, and 12 months after PICU discharge.

Anemia affects a large proportion of PICU survivors. This study will allow us to better understand the long-term prevalence and causes of anemia in this population as well as potential association with long-term outcome. Anemia (specifically iron responsive anemia) could be a potentially readily modifiable risk factor, to improve the long-term well-being of these children.

详细描述

Research Question/Objectives

Primary aim:

  1. To determine the prevalence of anemia in PICU survivors at 2 months post PICU discharge. Anemia is defined as per the World Health Organization criteria.

Hypothesis: Based on the adult literature and our preliminary data, we suspect that at least 30% of children will remain anemic at 2 months after PICU discharge.

Secondary aims: 2. To determine the prevalence of anemia in PICU survivors at 6 months and 12 months after PICU discharge. 3. To determine the association between post-PICU anemia and neurocognitive outcome at 2, 6, 12 months after PICU discharge. 4. To determine the association of post-PICU anemia with exercise tolerance at 2, 6, 12 months after PICU discharge. 5. To determine the association of post-PICU anemia with quality of life at 2, 6, 12 months after PICU discharge.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •are <18 years; AND 2) have a PICU length of stay at least 4 days; AND 3) required invasive mechanical ventilation ≥ 48 hours

排除标准

  • •we excluded children with 1) pre-existing hematologic disorder causing anemia, including treatment with immunosuppressant or cytotoxic drugs; 2) acute or chronic renal failure requiring renal replacement therapy at time of PICU admission; and 3) postoperative cardiac surgery. The local Institutional Review Board approved this study (#2019-2200).

结局指标

主要结局

Prevalence of anemia at 2 months post PICU discharge

时间窗: 2 months

we will measure peripheral blood count, which includes a hemoglobin concentration, in all patients at PICU discharge and at 2 months follow-up in patients found to be anemic at PICU discharge.

次要结局

  • Prevalence of anemia at 6 months and 12 months post PICU discharge(12 months)
  • The association between post-PICU anemia and neurocognitive outcome at 2, 6, 12 months after PICU discharge.(12 months)
  • The association of post-PICU anemia with quality of life at 2, 6, 12 months after PICU discharge.(12 months)
  • The etiology of anemia, by determining the blood levels of iron, transferrin, proportion of transferrin saturation, blood concentration of inflammatory markers - interleukin-6(IL-6), C-reactive protein and erythropoietin(12 months)
  • The PICU risks factors associated with post-PICU anemia(12 months)
  • The tolerance and compliance of patients treatment with iron at or after PICU discharge, if prescribed.(12 months)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Genevieve Du Pont-Thibodeau

Pediatric intensivist, MD, MSc, Associate Clinical Professor

St. Justine's Hospital

研究点 (1)

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