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临床试验/NCT04094428
NCT04094428招募中不适用

Burden, Mortality and Supply Costs in Intensive Care Unit Patients. Health Services Research.

University of Ulm1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2019年10月21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
700
试验地点
1
主要终点
Burden of care

研究概览

简要总结

This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

详细描述

This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

The 3 endpoints and 3 respective risk groups (high, intermediate, low) are

  1. Endpoint burden of care due to Clinical Frailty Scale (Frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4
  2. Endpoint mortality due to severity of disease regarding Simplified Acute Physiology Score (SAPS) II score values high SAPS II > 70, suspected mortality > 40% intermediate SAPS II > 40 - 70, suspected mortality 10 - 40% low SAPS II ≤ 40, suspected mortality < 10%
  3. Endpoint supply costs due to number of organ systems to be supported or replaced high ≥ 3 organ systems replaced intermediate 1 - 2 organ systems replaced low 0 - 2 organ systems replaced

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients dying on the ICU and all patients staying for at least 72 hours on the ICU

排除标准

  • 未提供

结局指标

主要结局

Burden of care

时间窗: 18 months

Organ dysfunctions supported or replaced in numbers

Mortality

时间窗: 18 months

Dying patients in numbers

Supply costs

时间窗: 18 months

Costs in sum of Simplified Acute Physiology Score (SAPS) II score points over ICU stay; Costs in sum of points of organ support over ICU stay; Costs in Euro reimbursed for the ICU stay

次要结局

未报告次要终点

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfred Weiss

Professor, MD

University of Ulm

研究点 (1)

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