This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.
Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate higher than 80% and 1-month mortality around 10%. There is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies highlighted that elderly patients often received suboptimal treatment: For example, less than a third of them received nitrates therapy while it is recommended. Furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality. The hypothesis of the Elisabeth Study s is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
503
The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management: 1. Treatment of the congestion: (international guidelines and recommendations) 2. Treatment of precipitating factors 3. NIV (non-invasive ventilation) if respiratory distress with hypercapnia and pH \< 7.35 in absence of contra indication. 4. Preventive LMWH (low molecular weight heparin) if no pre-existing anticoagulation therapy.
Emergency department Hospital Pitié-Salpêtrière
Paris, France
Number of days alive and out of hospital
Number of days alive and out of hospital
Time frame: 30 days
To evaluate the effect of AHF management on the 30-day cardiovascular death
cardiovascular death
Time frame: 30 days
To evaluate the effect of AHF management on the 30-day all causes death
all causes death
Time frame: 30 days
To evaluate the effect of AHF management on the hospital readmission at 30 days
hospital readmission
Time frame: 30 days
To evaluate the effect of AHF management on the length of stay in hospital
length of stay in hospital
Time frame: 30 days
To evaluate the effect of AHF management on changes of more than 2 fold in creatinine level from randomization to day 30 or to discharge whichever comes first
creatinine level
Time frame: 30 days
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