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临床试验/NCT02753023
NCT02753023Unknown不适用

Registry Of Acute meDical Emergencies in Brazil - ROAD-Brazil

University of Sao Paulo General Hospital6 个研究点 分布在 1 个国家目标入组 1,650 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,650
试验地点
6
主要终点
mortality

研究概览

简要总结

Critical patients in emergency room are seriously situations that need quickly diagnosis and treatment. Different predictors of prognosis can be related with mortality and morbidity in-hospital and in long-term. In Brazil, this kind of registry is not available. The aim of the study is analysis and report data about critical patients in Emergency Departments over all country, showing demographic, clinical and prognosis data about that in Brazil.

详细描述

This will be a prospective and multicentric data-bank registry. Initially, all patients with acute coronary syndromes (ACS), acute decompensated heart failure (ADHF), warfarin intoxication, acute pulmonary edema, acute aortic dissection, chest pain, pulmonary embolism and syncope will be included. There will be not exclusion criteria. The inclusion criteria will be followed by definition of each illness described in recent guidelines. Investigators estimated annually over than 500 cases with ACS/chest pain, 300 cases of ADHF, 200 cases of aortic dissection, 200 of pulmonary embolism, 200 cases of warfarin intoxication, 100 cases of syncope and 150 of acute pulmonary edema. Clinical data, electrocardiographic and echocardiographic findings, laboratory results and prognosis will be related. Routine of treatment will be defined by each center. The analysis includes minimum, medium and maximum values. Variables will be adjusted according with each diagnosis and all data will be included using the REDCap digital data entry. Probabilities will be determined by logistic regression and will be considered significate when p < 0.005. Prospectively, investigators will use the Cox model to calculate associations.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients with:
  • acute coronary syndromes (ACS) or,
  • acute decompensated heart failure (ADHF) or,
  • warfarin intoxication or,
  • acute pulmonary edema or,
  • acute aortic dissection or,
  • chest pain or,
  • pulmonary embolism or

排除标准

  • There will be not exclusion criteria.

结局指标

主要结局

mortality

时间窗: 6 months

次要结局

  • mortality(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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