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临床试验/NCT02946398
NCT02946398已完成不适用

Risk Stratification in Elderly Patients in the Emergency Department

Zuyderland Medisch Centrum2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年7月14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
600
试验地点
2
主要终点
30-day all cause mortality

研究概览

简要总结

Procedures for identification of high-risk elderly patients in the emergency department are lacking.

We aim to identify early risk factors associated with an adverse outcome in elderly patients who visit the emergency department (ED). Second, we aim to find practical tools to identify those elderly patients who are at risk for an adverse outcome in an early stage (by applying and testing triage and risk stratification scores, clinical impression and laboratory results).

With the results of this study, we intend to develop a clinical prediction model to identify older emergency department patients with an increased risk of adverse outcomes.

详细描述

Background:

Elderly patients (≥65 years of age) constitute an increasing population in emergency departments (EDs) in many countries. These patients are largely different from younger patients and undoubtedly need different approaches in acute care. Commonly used triage systems are not validated in elderly patients. We hypothesize that this factor contributes to a lack of recognition of patients at risk for adverse events or death.

Aim of the study:

  • At first, we will try to identify early risk factors associated with adverse outcome such as age, the premorbid state (comorbidity, living status and cognitive/functional state), medication use, vital signs, and number of previous visits to the ED.
  • Secondly, we will investigate the discriminating power of several triage and risk stratification scores. In our study, we will retrieve and validate the following triage and risk stratification scores: The Manchester Triage System (MTS) triage score, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score and the Identification of Seniors At Risk-Hospitalised Patients (ISAR-HP) score for all hospitalized patients. Furthermore, we will calculate four well-known disease specific stratification scores: The Glasgow-Blatchford Bleeding (GBS Score) for patients with an upper gastrointestinal bleeding, the Abbreviated Mortality ED Sepsis (abbMEDS) score and Sepsis-related Organ Failure Assessment (SOFA) score and the Confusion, Urea, Respiration, Blood pressure, Age >65 years (CURB-65) score.
  • Thirdly, we will investigate the predictive value of the clinical impression of professionals (doctor/nurse) and the disease perception of patient/companion.
  • Fourth, we will investigate the predictive value of laboratory tests (routine tests and biomarkers like lactate, N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), high-sensitivity troponin (hs-TnT), procalcitonin (PCT) and d-dimer.
  • At last, we intend to develop a clinical prediction model for short-term mortality and test the predictive ability of this model for the other adverse outcomes/endpoints. This model will be validated in an external cohort.

Study procedure:

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥65 years
  • Visit to the emergency department for the internist/gastroenterologist
  • Informed consent

排除标准

  • Earlier participation in study (patients can only be included once)
  • No informed consent
  • Inability to speak Dutch or English
  • Admission to a ward of another specialty than internal medicine/gastroenterology

结局指标

主要结局

30-day all cause mortality

时间窗: 30 days

all cause mortality within 30 days (both in- and out-hopsital)

次要结局

  • composite secondary outcome(30 days or 30 days after hospital discharge)
  • all cause mortality after 1 year(1 year)

研究者

发起方
Zuyderland Medisch Centrum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacqueline Buijs

Internist

Zuyderland Medisch Centrum

研究点 (2)

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