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临床试验/NCT04581655
NCT04581655已完成不适用

Retrospective and Prospective Analysis of Risk and Outcome Factors in Oncohematological Patients Admitted to Italian Pediatric Intensive Care Units: a Multicenter Study

Azienda Ospedaliera di Padova17 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
17
主要终点
neurological outcome

研究概览

简要总结

The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.

详细描述

The study aim to evaluate:

  1. characteristics of pediatric cancer patients admitted to Italian PICUs
  2. risk factors of PICU admission, neurological outcome and mortality.

Inclusion criteria: age <= 18 years, informed consent. Exclusion criteria: informed consent not obtained. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months (March 2021 - February 2021) gathering data from 15-20 Italian PICUs. Each Center can decide whether to participate only in the prospective phase. Data will be recorded in an electronic data collection form in Red Cap.

The following variables will be collected:

  • Demographic variables: age, sex, ethnicity;
  • TIP pre-admission clinical variables and at the time of admission: basic diagnosis, comorbidity, Hemopoietic Stem Cell Transplantation (TCSE) number and type, treatment phase, HLA matching, Graft Versus Host (GVH) and grade, veno-occlusive disease, Venous Occlusive Disease
  • Variables upon entering TIP: PIM3, POPC score, organ failure cause and staging, high intensity treatments, high flow oxygen therapy, dialysis, inotropes or other, fluid overload, immunodeficiency
  • Clinical variables during hospitalization: organ failure cause and staging, ventilation, modality, presence of pARDS and severity, need for inotropic support, sepsis and severity score (SOFA), inotropes (VIS score), arrest event cardiac, need for HFOV, Extra-Corporeal Membrane Oxygenator, Nitric Oxide, dialysis, Intracranial Pressure monitoring, drugs used for sedation, development of withdrawal syndrome, development of delirium.

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

入选标准

  • age <= 18 yeras
  • informed consent*

排除标准

  • informed consent not obtained*
  • only for next prospective part of the study

结局指标

主要结局

neurological outcome

时间窗: on date of PICU discharge assessed up to 10 days

patients's Pediatric Overall Performance Category (POPC) score (a 6 level score: 4 to 6 is considered bad outcome)

mortality

时间窗: from 31st to 90th day after PICU discharge

90-days mortality

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera di Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

angela amigoni

Principal Investigator

Azienda Ospedaliera di Padova

研究点 (17)

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