跳至主要内容
临床试验/NCT01924663
NCT01924663已完成不适用

Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.

研究概览

简要总结

The purpose of this study is to be able to better describe the incidence, timing and severity of myocardial dysfunction and acute kidney injury (AKI) following a documented respiratory viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.) in pediatric patients.

详细描述

This is a single-centre, prospective and retrospective, descriptive data-collection pilot study.

Prospective Data Collection:

All pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab will be invited to participate.

Retrospective Data Collection:

The retrospective portion of this study will examine a 5 year period prior to the start of enrollment for the prospective study, with the intention to include all pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab and admitted into the local hospital's PICU.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

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

入选标准

  • The parent or legal guardian of the pediatric subject must sign the Consent Form for participants in the prospective portion of the study.
  • The subject must be no greater than 18 years of age, at the time of consent.
  • The subject must be admitted to the local hospital.
  • The subject must have a confirmed positive respiratory viral swab.

排除标准

  • The parent or legal guardian of the pediatric subject is unavailable or unwilling to sign the Consent Form for participants in the prospective portion of the study.
  • The subject has had previous kidney injury or myocardial dysfunction prior to positive respiratory viral swab.
  • The subject has any previous problems (prior to positive respiratory viral swab) with their heart or kidneys that could compromise the results, in the opinion of the Investigator.

结局指标

主要结局

Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.

时间窗: up to 7 days

Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria.

时间窗: up to 7 days

次要结局

未报告次要终点

研究者

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

Tanya Holt

Principal Investigator, Director of Paediatric Critical Care

University of Saskatchewan

研究点 (1)

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