The Triple A Initiative Study (“Aktionsbündnis Akute Atemnot”)

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

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.

Interventions

  • Device: NTproBNP measurement with point of care device “Cobash232″ in the POCT group

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Days alive and out of hospital within 30 days
    • Time Frame: 30 days

Secondary Measures

  • Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days
    • Time Frame: 60 months
  • Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure
    • Time Frame: 1 month
  • In-hospital length of stay during follow-up of 30 and 90 days
    • Time Frame: 3 months
  • Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission
    • Time Frame: 1 month
  • Need for ICU admission during initial hospitalization
    • Time Frame: 6 months
  • B-type natriuretic peptide level and calculated glomerular filtration rate at discharge
    • Time Frame: 6 months
  • Patients functional status at 30, 90 and 180 days (Barthel Index)
    • Time Frame: 6 months
  • Mortality at 30, 90 and 180 days
    • Time Frame: 6 months
  • Total treatment costs at 30, 90 and 180 days
    • Time Frame: 6 months
  • Days alive and out of hospital at 90 and 180 days
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prof. Dr. Michael Christ
  • Collaborator
    • Jena University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ – Klinikum Nürnberg
  • Overall Official(s)
    • Michael Christ, Prof., Principal Investigator, Klinikum Nürnberg

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