A Prospective Randomized Study of Coordinated Diagnostic Pathways and Treatment Algorithms for Patients With Acute Dyspnea Including Point-of-care Testing of a Cardiac Biomarker by the Emergency Medical Service Team
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Days alive and out of hospital within 30 days
研究概览
简要总结
Acute dyspnea is a common chief complaint of patients presenting to the emergency department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A Initiative Study is designed to improve the coordination of care for patients with acute dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of care starting at the EMS level including point-of-care testing of the cardiac biomarker NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving from earlier diagnostic clarification will reduce length of stay in the hospital, treatment costs and improve patient's outcome.
详细描述
The aim of this prospective, randomized study is to evaluate the effects of point-of-care testing of NT-proBNP in patients presenting with acute dyspnea to the Emergency Medical Service (EMS).Patients will be enrolled in the Emergency Medical Services of participating German hospitals (Klinikum Nürnberg, Klinikum Fürth, Universitätsklinikum Jena). To be enrolled in the study, each patient must meet all of the following inclusion criteria and none of the exclusion criteria.
Patients with acute dyspnea randomized to the POCT group will get a NT-proBNP-POCT measurement in the EMS. The emergency physician of the EMS will decide to apply predefined treatment strategies according to the resulting working hypothesis. Patients with acute dyspnea randomized to the standard care group will NOT get NT-proBNP measurement at the scene. The emergency physician of the ED will construct the working hypothesis following current treatment recommendations. The major focus of the study is to initiate treatment of heart failure as early as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute dyspnea (NYHA II-IV)
- •age >= 18 years
- •informed consent
排除标准
- •cardiopulmonary resuscitation < 7 days
- •cardiogenic shock, STEMI, respiratory failure, or other clinical conditions that require immediate intensive care admission or angioplasty
- •systolic blood pressure lower than 100 mmHg at first contact/presentation
- •ventricular tachycardia
- •severe aortic stenosis
- •advanced neoplasm (e.g. lung cancer, hematologic neoplasm, etc.)
- •chronic kidney disease requiring hemodialysis
结局指标
主要结局
Days alive and out of hospital within 30 days
时间窗: 30 days
次要结局
- Days alive and out of hospital at 90 and 180 days(6 months)
- Need for ICU admission during initial hospitalization(6 months)
- Patients functional status at 30, 90 and 180 days (Barthel Index)(6 months)
- Mortality at 30, 90 and 180 days(6 months)
- Total treatment costs at 30, 90 and 180 days(6 months)
- Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days(60 months)
- Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure(1 month)
- In-hospital length of stay during follow-up of 30 and 90 days(3 months)
- Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission(1 month)
- B-type natriuretic peptide level and calculated glomerular filtration rate at discharge(6 months)
研究者
Prof. Dr. Michael Christ
Prof. Dr. med. Michael Christ
Klinikum Nürnberg