The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")

Prof. Dr. Michael Christ

Status: Terminated

Conditions: Dyspnea; Heart Failure

Treatments: Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02049853

TripleA01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

default group

No Intervention group

Description:

Patients with the randomization result "default group" receive standard diagnostics

POCT group

Active Comparator group

Description:

patients with the randomization result "POCT group" receive a NTproBNP measurement with point of care device "Cobash232" in the ambulance vehicle

Treatment:

Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group