Not provided
Not provided
Not provided
Not provided
Not provided
recruitment numbers lower than expected
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jena University Hospital | OTHER |
| City Hospital Fürth | OTHER |
| Roche Pharma AG | INDUSTRY |
| Bayrisches Rotes Kreuz Fuerth |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| default group | No Intervention | Patients with the randomization result "default group" receive standard diagnostics | |
| POCT group | Active Comparator | patients with the randomization result "POCT group" receive a NTproBNP measurement with point of care device "Cobash232" in the ambulance vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTproBNP measurement with point of care device "Cobash232" in the POCT group | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital within 30 days | 30 days |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Christ, Prof. | Klinikum Nürnberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Nürnberg | Nuremberg | Bavaria | 90419 | Germany | ||
| Bayrisches Rotes Kreuz |
Not provided
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| UNKNOWN |
| Johanniter Unfall Hilfe Nürnberg | UNKNOWN |
| DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Fürth |
| 90762 |
| Germany |
| Klinikum Fürth, Emergency Department | Fürth | 90766 | Germany |
| Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine | Jena | 07747 | Germany |
| DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V. | Jena | 07749 | Germany |
| Johanniter-Unfall-Hilfe | Nuremberg | 90419 | Germany |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |