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

Primary Purpose

Dyspnea, Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NTproBNP measurement with point of care device "Cobash232" in the POCT group
Sponsored by
Prof. Dr. Michael Christ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspnea focused on measuring acute dyspnea, heart failure, diagnostics, POCT analysis, preclinical area

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Nürnberg
  • Bayrisches Rotes Kreuz
  • Klinikum Fürth, Emergency Department
  • Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine
  • DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
  • Johanniter-Unfall-Hilfe

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

default group

POCT group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Days alive and out of hospital within 30 days

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
Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure
In-hospital length of stay during follow-up of 30 and 90 days
Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission
Need for ICU admission during initial hospitalization
B-type natriuretic peptide level and calculated glomerular filtration rate at discharge
Patients functional status at 30, 90 and 180 days (Barthel Index)
Mortality at 30, 90 and 180 days
Total treatment costs at 30, 90 and 180 days
Days alive and out of hospital at 90 and 180 days

Full Information

First Posted
January 28, 2014
Last Updated
May 19, 2015
Sponsor
Prof. Dr. Michael Christ
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.
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1. Study Identification

Unique Protocol Identification Number
NCT02049853
Brief Title
The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
recruitment numbers lower than expected
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Michael Christ
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.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Heart Failure
Keywords
acute dyspnea, heart failure, diagnostics, POCT analysis, preclinical area

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
default group
Arm Type
No Intervention
Arm Description
Patients with the randomization result "default group" receive standard diagnostics
Arm Title
POCT group
Arm Type
Active Comparator
Arm Description
patients with the randomization result "POCT group" receive a NTproBNP measurement with point of care device "Cobash232" in the ambulance vehicle
Intervention Type
Device
Intervention Name(s)
NTproBNP measurement with point of care device "Cobash232" in the POCT group
Primary Outcome Measure Information:
Title
Days alive and out of hospital within 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
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
Title
Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure
Time Frame
1 month
Title
In-hospital length of stay during follow-up of 30 and 90 days
Time Frame
3 months
Title
Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission
Time Frame
1 month
Title
Need for ICU admission during initial hospitalization
Time Frame
6 months
Title
B-type natriuretic peptide level and calculated glomerular filtration rate at discharge
Time Frame
6 months
Title
Patients functional status at 30, 90 and 180 days (Barthel Index)
Time Frame
6 months
Title
Mortality at 30, 90 and 180 days
Time Frame
6 months
Title
Total treatment costs at 30, 90 and 180 days
Time Frame
6 months
Title
Days alive and out of hospital at 90 and 180 days
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Christ, Prof.
Organizational Affiliation
Klinikum Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Nürnberg
City
Nuremberg
State/Province
Bavaria
ZIP/Postal Code
90419
Country
Germany
Facility Name
Bayrisches Rotes Kreuz
City
Fürth
ZIP/Postal Code
90762
Country
Germany
Facility Name
Klinikum Fürth, Emergency Department
City
Fürth
ZIP/Postal Code
90766
Country
Germany
Facility Name
Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
City
Jena
ZIP/Postal Code
07749
Country
Germany
Facility Name
Johanniter-Unfall-Hilfe
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany

12. IPD Sharing Statement

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

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