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临床试验/NCT02643459
NCT02643459已完成不适用

Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2016年1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
20,000
试验地点
2
主要终点
All Cause Mortality

研究概览

简要总结

Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?

详细描述

In a health care system where the general population is growing, more patients are living with chronic conditions and the hospitals are reducing beds and length of stay, it is crucial to perform safe and fast risk stratification of patients presenting in the Emergency departments. Risk stratification is currently performed with a combination of measurement of the vital signs and assessment of the primary complaint. The aim of the current study is to assess whether the supplement of biomarkers can improve the risk stratification in regard to mortality, readmissions and improve overall patient flow in the Emergency departments. Soluble urokinase plasminogen activating receptor (suPAR) is the soluble form of urokinase-type plasminogen activator receptor (uPAR). uPAR is present on various immunological active cells, as well as endothelia and smooth muscle cells. It is believed that suPAR mirrors the inflammatory response in patients. Previous studies have shown a strong association with mortality and severity of disease in a broad variety of conditions (infection, hepatic-, renal-, cardiac- and lung disease) as well as a possible marker of disease development in the general population. These abilities indicate that suPAR although unspecific would be ideal to identify patients at high- and at low-risk. The aim is to target interventions and limited clinical focus where it is most beneficial. In unselected patients suPAR is one of the strongest prognostic biomarker available to date.

It is not known whether information on prognosis in the Emergency department can be used to prevent death, serious complications or reduce admissions and readmissions.

The purpose of the current study is to examine if introduction of the biomarker suPAR and education of doctors in the meaning of suPAR levels and association to disease, can reduce mortality, admissions and readmission in patients referred to the emergency rooms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.

排除标准

  • Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.

结局指标

主要结局

All Cause Mortality

时间窗: 10 months after the inclusions period ends mortality data will be assessed

Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.

次要结局

  • Number of Discharges From the Emergency Room Within 24 Hours(24 hours)
  • Number of Patients With an Admission to the Intensive Care Unit(30 days)
  • All Cause Mortality(1 months after index admission mortality data will assessed)
  • Number of Admissions to the Medical Ward(30 days)
  • Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups(10 months after inclusion period ends)
  • Length of Stay During Admission.(30 days)
  • Number of Readmissions(90 days)

研究者

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

Martin Schultz

MD, P.h.D student

Herlev Hospital

研究点 (2)

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