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Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial (ELISABETH)

Primary Purpose

Acute Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early intensive care bundle
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Emergency department, Elderly, Acute heart failure, Pulmonary edema

Eligibility Criteria

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

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:

    • at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea
    • one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP).
    • Patients affiliated to French social security ("AME excepted")
    • Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)

Exclusion Criteria:

  • Patients are excluded if they have any of the followings:

    • other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction)
    • systolic blood pressure less than 100 mmHg
    • severe mitral or aortic stenosis, or severe aortic regurgitation
    • known chronic kidney injury on dialysis
    • shock from any cause
    • Time from ED entrance to inclusion > 6h
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Sites / Locations

  • Emergency department Hospital Pitié-Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention period : early and comprehensive care bundle

acute heart failure standard therapy

Arm Description

Outcomes

Primary Outcome Measures

Number of days alive and out of hospital
Number of days alive and out of hospital

Secondary Outcome Measures

To evaluate the effect of AHF management on the 30-day cardiovascular death
cardiovascular death
To evaluate the effect of AHF management on the 30-day all causes death
all causes death
To evaluate the effect of AHF management on the hospital readmission at 30 days
hospital readmission
To evaluate the effect of AHF management on the length of stay in hospital
length of stay in hospital
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

Full Information

First Posted
July 9, 2018
Last Updated
July 1, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03683212
Brief Title
Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial
Acronym
ELISABETH
Official Title
Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Emergency department, Elderly, Acute heart failure, Pulmonary edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention period : early and comprehensive care bundle
Arm Type
Experimental
Arm Title
acute heart failure standard therapy
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Early intensive care bundle
Intervention Description
The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management: Treatment of the congestion: (international guidelines and recommendations) Treatment of precipitating factors NIV (non-invasive ventilation) if respiratory distress with hypercapnia and pH < 7.35 in absence of contra indication. Preventive LMWH (low molecular weight heparin) if no pre-existing anticoagulation therapy.
Primary Outcome Measure Information:
Title
Number of days alive and out of hospital
Description
Number of days alive and out of hospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
To evaluate the effect of AHF management on the 30-day cardiovascular death
Description
cardiovascular death
Time Frame
30 days
Title
To evaluate the effect of AHF management on the 30-day all causes death
Description
all causes death
Time Frame
30 days
Title
To evaluate the effect of AHF management on the hospital readmission at 30 days
Description
hospital readmission
Time Frame
30 days
Title
To evaluate the effect of AHF management on the length of stay in hospital
Description
length of stay in hospital
Time Frame
30 days
Title
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
Description
creatinine level
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP). Patients affiliated to French social security ("AME excepted") Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code) Exclusion Criteria: Patients are excluded if they have any of the followings: other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction) systolic blood pressure less than 100 mmHg severe mitral or aortic stenosis, or severe aortic regurgitation known chronic kidney injury on dialysis shock from any cause Time from ED entrance to inclusion > 6h Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonathan Freund, Doctor
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department Hospital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33201202
Citation
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.
Results Reference
derived
PubMed Identifier
30704508
Citation
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.
Results Reference
derived

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Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial

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