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Trial record 1 of 16 for:    Triple A Initiative Study
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The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049853
Recruitment Status : Terminated (recruitment numbers lower than expected)
First Posted : January 30, 2014
Last Update Posted : May 20, 2015
Sponsor:
Collaborators:
Jena University Hospital
City Hospital Fürth
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dyspnea Heart Failure Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Days alive and out of hospital within 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure [ Time Frame: 1 month ]
  3. In-hospital length of stay during follow-up of 30 and 90 days [ Time Frame: 3 months ]
  4. Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission [ Time Frame: 1 month ]
  5. Need for ICU admission during initial hospitalization [ Time Frame: 6 months ]
  6. B-type natriuretic peptide level and calculated glomerular filtration rate at discharge [ Time Frame: 6 months ]
  7. Patients functional status at 30, 90 and 180 days (Barthel Index) [ Time Frame: 6 months ]
  8. Mortality at 30, 90 and 180 days [ Time Frame: 6 months ]
  9. Total treatment costs at 30, 90 and 180 days [ Time Frame: 6 months ]
  10. Days alive and out of hospital at 90 and 180 days [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049853


Locations
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Germany
Klinikum Nürnberg
Nuremberg, Bavaria, Germany, 90419
Bayrisches Rotes Kreuz
Fürth, Germany, 90762
Klinikum Fürth, Emergency Department
Fürth, Germany, 90766
Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine
Jena, Germany, 07747
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
Jena, Germany, 07749
Johanniter-Unfall-Hilfe
Nuremberg, Germany, 90419
Sponsors and Collaborators
Prof. Dr. Michael Christ
Jena University Hospital
City Hospital Fürth
Roche Pharma AG
Bayrisches Rotes Kreuz Fuerth
Johanniter Unfall Hilfe Nürnberg
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
Investigators
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Principal Investigator: Michael Christ, Prof. Klinikum Nürnberg
More Information
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Responsible Party: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT02049853    
Other Study ID Numbers: TripleA01
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Prof. Dr. Michael Christ, Klinikum Nürnberg:
acute dyspnea
heart failure
diagnostics
POCT analysis
preclinical area
Additional relevant MeSH terms:
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Dyspnea
Heart Failure
Heart Diseases
Cardiovascular Diseases
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory