The Triple A Initiative Study (Aktionsbündnis Akute Atemnot)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dyspnea, Heart Failure

Intervention / Treatment
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* Device: NTproBNP measurement with point of care device Cobash232 in the POCT group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute dyspnea (NYHA II-IV) age >= 18 years informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: default group<br>Patients with the randomization result default group receive standard diagnostics | |
| Active Comparator: POCT group<br>patients with the randomization result POCT group receive a NTproBNP measurement with point of care device Cobash232 in the ambulance vehicle | Device: NTproBNP measurement with point of care device Cobash232 in the POCT group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days alive and out of hospital within 30 days |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Need for ICU admission during initial hospitalization |  | 6 months | 
| B-type natriuretic peptide level and calculated glomerular filtration rate at discharge |  | 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 | 
| Days alive and out of hospital at 90 and 180 days |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute dyspnea, heart failure, diagnostics, POCT analysis, preclinical area