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

NCT ID: NCT02049853

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Dyspnea; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

default group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

POCT group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: collaborator

City Hospital Fürth

OTHER

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Bayrisches Rotes Kreuz Fuerth

UNKNOWN

Sponsor Role: collaborator

Johanniter Unfall Hilfe Nürnberg

UNKNOWN

Sponsor Role: collaborator

DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. Michael Christ

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Michael Christ

Prof. Dr. med. Michael Christ

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Christ, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Nürnberg

Locations

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

Bayrisches Rotes Kreuz

Fürth, , Germany

Klinikum Fürth, Emergency Department

Fürth, , Germany

Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine

Jena, , Germany

DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.

Jena, , Germany

Johanniter-Unfall-Hilfe

Nuremberg, , Germany

Countries

Germany

Other Identifiers

TripleA01

Identifier Type: -

Identifier Source: org_study_id