An interventional study of NTproBNP measurement with point of care device "Cobash232" in the POCT group in Dyspnea and Heart Failure, sponsored by Prof. Dr. Michael Christ. Terminated at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-20.
Sponsored by Prof. Dr. Michael Christ · Not applicable, Interventional, and Diagnostic
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.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 67 is above the median of 48 across 430 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →This is the only study on the registry with Prof. Dr. Michael Christ as lead sponsor.
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Exclusion Criteria:
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
Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group
Days alive and out of hospital within 30 days
Time frame: 30 days
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
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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