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Follow-up of Oncology Patients After Hospitalization in ICU (SALTO)

2021年1月12日 更新者:Assistance Publique - Hôpitaux de Paris

"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.

Main purpose of research :

Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay

Secondary objective of the research :

Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.

Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.

Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "

研究概览

地位

完全的

条件

详细说明

"Nature of evaluated care: Longitudinal follow-up of post- resuscitation intensive care Concerned population: adult patients with active solid tumor out alive from the ICU and following-up in oncology in the same hospital as the resuscitator investigator.

Main objective: Measure the influence of ICU for patients with solid cancers to continue with optimal anti -cancer treatment, defined before or during hospitalization in intensive care.

Secondary objective: Assess the physical and psychological consequences of ICU stay of patients Evaluation criteria : Primary endpoint: proportion of patients living, out from ICU and hospital, can receive optimal cancer treatment later.

Research Methodology : Prognostic study of routine care, national, prospective, cohort type."

研究类型

观察性的

注册 (实际的)

309

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Montfermeil、法国、93370
        • CHI Le Raincy-Montfermeil

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

adult patients with active solid tumor out alive from the ICU and monitoring in oncology in the same hospital as the resuscitator investigator.

描述

Inclusion criteria:

  • Patient with progressive solid tumor hospitalized in intensive care and got out alive
  • Oncology patients followed in the same hospital as the investigator resuscitator
  • Age ≥ 18 years
  • Affiliate of social insurance
  • Agree to participate

Exclusion criteria :

  • Patient hospitalized for programed surgery
  • Hospitalization for securing procedure
  • Pregnancy or breastfeeding woman

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Proportion of patients with cancer admitted in ICU who will be eligible for optimal anti-cancer treatment after discharge from ICU
大体时间:Months12
Months12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年1月1日

初级完成 (实际的)

2017年12月1日

研究完成 (实际的)

2019年12月17日

研究注册日期

首次提交

2014年12月19日

首先提交符合 QC 标准的

2015年3月20日

首次发布 (估计)

2015年3月26日

研究记录更新

最后更新发布 (实际的)

2021年1月13日

上次提交的符合 QC 标准的更新

2021年1月12日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • KI120906
  • 2013-A00683-42 (其他标识符:ANSM)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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