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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Klinikum Nürnberg
Sponsor:
Collaborators:
Jena University Hospital
City Hospital Fuerth
Roche Pharma AG
Bayrisches Rotes Kreuz Fuerth
Johanniter Unfall Hilfe Nürnberg
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
Information provided by (Responsible Party):
Prof. Dr. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier:
NCT02049853
First received: January 28, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Dyspnea
Heart Failure
Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Klinikum Nürnberg:

Primary Outcome Measures:
  • Days alive and out of hospital within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • In-hospital length of stay during follow-up of 30 and 90 days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Need for ICU admission during initial hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • B-type natriuretic peptide level and calculated glomerular filtration rate at discharge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patients functional status at 30, 90 and 180 days (Barthel Index) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mortality at 30, 90 and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total treatment costs at 30, 90 and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Days alive and out of hospital at 90 and 180 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 460
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049853

Contacts
Contact: Michael Christ, Prof. +49 911 398 2369 michael.christ@klinikum-nuernberg.de

Locations
Germany
Klinikum Nürnberg Recruiting
Nuremberg, Bavaria, Germany, 90419
Contact: Michael Christ, Prof.    +49 911 398 2369    michael.christ@klinikum-nuernberg.de   
Contact: Felicitas Geier, M. Sc.    +49 911 398 5561    felicitas.geier@klinikum-nuernberg.de   
Principal Investigator: Michael Christ, Prof.         
Klinikum Fürth, Emergency Department Recruiting
Fürth, Germany, 90766
Contact: Harald Dormann, Prof.    +49 911 7580992808    harald.dormann@klinikum-fuerth.de   
Principal Investigator: Harald Dormann, Prof.         
Bayrisches Rotes Kreuz Recruiting
Fürth, Germany, 90762
Contact: Marcus Milde    +49 911 77981-39      
Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine Recruiting
Jena, Germany, 07747
Contact: Johannes Winning, Dr.    +49 3641 9323101    Johannes.Winning@med.uni-jena.de   
Principal Investigator: Johannes Winning, Dr.         
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V. Recruiting
Jena, Germany, 07749
Johanniter-Unfall-Hilfe Recruiting
Nuremberg, Germany, 90419
Contact: Michael Seitz    +49 911 27257 50      
Sponsors and Collaborators
Prof. Dr. Michael Christ
Jena University Hospital
City Hospital Fuerth
Roche Pharma AG
Bayrisches Rotes Kreuz Fuerth
Johanniter Unfall Hilfe Nürnberg
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
Investigators
Principal Investigator: Michael Christ, Prof. Klinikum Nürnberg
  More Information

No publications provided

Responsible Party: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT02049853     History of Changes
Other Study ID Numbers: TripleA01
Study First Received: January 28, 2014
Last Updated: January 28, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Nürnberg:
acute dyspnea
heart failure
diagnostics
POCT analysis
preclinical area

Additional relevant MeSH terms:
Heart Failure
Dyspnea
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014