Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 9
- 主要终点
- Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology
研究概览
简要总结
Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish databases show, that patients with shortness of breath in the ambulance have a very high mortality. Breathlessness can be caused by many different conditions - but heart diseases and lung diseases are dominant. The mortality is especially high in patients with breathlessness caused by heart disease.
Distinguishing these different causes of breathlessness is a classical, often difficult, discipline in medicine. Visitation and guidance of treatment in patients with breathlessness in the prehospital setting relies on medical history and physical examination and as a consequence prehospital treatment for breathlessness is often non-specific. The use of heart-failure specific biomarkers may improve prehospital visitation and treatment of patients with breathlessness.
We hypothesize, that
- Supplementing the routine examination by prehospital anesthesiologist with measurement of a biomarker for heart failure increases the proportion of patients with severe shortness of breath caused by heart disease triaged directly to department of cardiology
- This strategy does not increase the proportion of patients with severe shortness of breath caused by non-heart disease triaged directly to department of cardiology
详细描述
Measurement of the biomarker for heart failure N-terminal pro-Brain Natriuretic Peptide (NT-proBNP):
In patients randomized to the strategy with supplementary measurement of NT-proBNP, a blood sample will be drawn from the peripheral venous catheter that is routinely inserted. This will be analyzed point-of-care in the ambulance.
Interpretation of NT-proBNP:
Cut-off values based on bootstrap-validated optimal cut-points for heart failure on will be used.
Confirmatory ('rule in') cut point
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
- Single (Outcomes Assessor)
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
- •All patients requiring dispatch of emergency physician because of severe dyspnea.
- •Severe dyspnea is defined by dyspnea plus at least ONE of the following
- •Respiration frequency > 20 or < 8
- •Saturation < 96 without supplementary oxygen
- •Heart rate > 100 or < 50
- •Systolic blood pressure < 100 or > 200
- •Difficulty talking
- •Central or peripheral cyanosis
- •Use of accessory muscles of respiration
- •Glasgow coma scale score < 15
- •AND because of the physical condition, the patient is not able to give informed consent
排除标准
- 未提供
研究组 & 干预措施
Business as usual
Triage and treatment based on routine clinical assessment as usual
Supplementary NT-proBNP measurement
Triage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP
干预措施: Supplementary NT-proBNP measurement (Other)
结局指标
主要结局
Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology
时间窗: Within 1 day from randomization
An endpoint committee determines final diagnoses as "dyspnea caused by heart disease", "dyspnea caused by lung disease" and "dyspnea caused by other diseases" based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
次要结局
- Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology(Within 1 day from randomization)
- All-cause mortality(Within 30 days of randomization)
- Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication(Within 1 day)
- Proportion of patients not admitted to hospital(Within 24 hours)
- Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication(Within 1 day)
- Length of hospital stay(Up to three months from randomization)
- Intensive care unit admission rate(Up to three months from randomization)
- All-cause re-admission(Within 3 months of randomization)
- Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting(Within 1 day of randomization)
- Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting(Within 1 day of randomization)
研究者
Morten Thingemann Bøtker
MD, PhD student
University of Aarhus