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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01139-46 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention period : early and comprehensive care bundle | Experimental |
| |
| acute heart failure standard therapy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early intensive care bundle | Procedure | The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days alive and out of hospital | Number of days alive and out of hospital | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of AHF management on the 30-day cardiovascular death | cardiovascular death | 30 days |
| To evaluate the effect of AHF management on the 30-day all causes death | all causes death |
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Inclusion Criteria:
Patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of:
Exclusion Criteria:
Patients are excluded if they have any of the followings:
Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
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| Name | Affiliation | Role |
|---|---|---|
| Yonathan Freund, Doctor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency department Hospital Pitié-Salpêtrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33201202 | Derived | Freund Y, Cachanado M, Delannoy Q, Laribi S, Yordanov Y, Gorlicki J, Chouihed T, Feral-Pierssens AL, Truchot J, Desmettre T, Occelli C, Bobbia X, Khellaf M, Ganansia O, Bokobza J, Balen F, Beaune S, Bloom B, Simon T, Mebazaa A. Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial. JAMA. 2020 Nov 17;324(19):1948-1956. doi: 10.1001/jama.2020.19378. | |
| 30704508 |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| D011654 | Pulmonary Edema |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
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|
| 30 days |
| To evaluate the effect of AHF management on the hospital readmission at 30 days | hospital readmission | 30 days |
| To evaluate the effect of AHF management on the length of stay in hospital | length of stay in hospital | 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 | 30 days |
| Derived |
| Freund Y, Gorlicki J, Cachanado M, Salhi S, Lemaitre V, Simon T, Mebazaa A. Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped-wedge cluster randomized trial. Trials. 2019 Jan 31;20(1):95. doi: 10.1186/s13063-019-3188-8. |
| D012140 | Respiratory Tract Diseases |