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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Dyspnea
• Intervention / Treatment: Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Fürth, Germany, 90762
    • Bayrisches Rotes Kreuz
  • Fürth, Germany, 90766
    • Klinikum Fürth, Emergency Department
  • Jena, Germany, 07747
    • Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine
  • Jena, Germany, 07749
    • DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
  • Nuremberg, Germany, 90419
    • Johanniter-Unfall-Hilfe
  • Bavaria
    • Nuremberg, Bavaria, Germany, 90419
      • Klinikum Nürnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: default group; Patients with the randomization result "default group" receive standard diagnostics
Active Comparator: POCT group; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Prof. Dr. Michael Christ
• Collaborators: Roche Pharma AG; Jena University Hospital; City Hospital Fürth; Bayrisches Rotes Kreuz Fuerth; Johanniter Unfall Hilfe Nürnberg; DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
• Investigators: Principal Investigator: Michael Christ, Prof., Klinikum Nürnberg

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: heart failure; diagnostics; acute dyspnea; POCT analysis; preclinical area
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Heart Failure; Dyspnea
• Other Study ID Numbers: TripleA01