Clinical trial NCT02049853: The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Heart Failure
Keywords: acute dyspnea
heart failure
diagnostics
POCT analysis
preclinical area
Lead sponsor: Klinikum Nürnberg
Sponsor class: OTHER
Collaborators: name: Jena University Hospital
name: City Hospital Fürth
name: Roche Pharma AG
name: Bayrisches Rotes Kreuz Fuerth
name: Johanniter Unfall Hilfe Nürnberg
name: DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
First posted: 2014-01-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Days alive and out of hospital within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days
timeFrame: 60 months
measure: Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure
timeFrame: 1 month
measure: In-hospital length of stay during follow-up of 30 and 90 days
timeFrame: 3 months
measure: Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission
timeFrame: 1 month
measure: Need for ICU admission during initial hospitalization
timeFrame: 6 months
measure: B-type natriuretic peptide level and calculated glomerular filtration rate at discharge
timeFrame: 6 months
measure: Patients functional status at 30, 90 and 180 days (Barthel Index)
timeFrame: 6 months
measure: Mortality at 30, 90 and 180 days
timeFrame: 6 months
measure: Total treatment costs at 30, 90 and 180 days
timeFrame: 6 months
measure: Days alive and out of hospital at 90 and 180 days
timeFrame: 6 months
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: Klinikum Nürnberg
state: Bavaria
city: Fürth
country: Germany
facility: Bayrisches Rotes Kreuz
city: Fürth
country: Germany
facility: Klinikum Fürth, Emergency Department
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine
city: Jena
country: Germany
facility: DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
city: Nuremberg
country: Germany
facility: Johanniter-Unfall-Hilfe
Study officials:
affiliation: Klinikum Nürnberg
name: Michael Christ, Prof.
role: PRINCIPAL_INVESTIGATOR
References: