NCT03683212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2019

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

July 9, 2018

Last Update Submit

July 1, 2020

Conditions

Acute Heart Failure

Keywords

Emergency departmentElderlyAcute heart failurePulmonary edema

Outcome Measures

Primary Outcomes (1)

  • Number of days alive and out of hospital

    Number of days alive and out of hospital

    30 days

Secondary Outcomes (5)

  • To evaluate the effect of AHF management on the 30-day cardiovascular death

    30 days

  • To evaluate the effect of AHF management on the 30-day all causes death

    30 days

  • To evaluate the effect of AHF management on the hospital readmission at 30 days

    30 days

  • To evaluate the effect of AHF management on the 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

    30 days

Study Arms (2)

Intervention period : early and comprehensive care bundle

EXPERIMENTAL
Procedure: Early intensive care bundle

acute heart failure standard therapy

NO INTERVENTION

Interventions

Early intensive care bundlePROCEDURE

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.

Intervention period : early and comprehensive care bundle

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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")

You may not qualify if:

  • 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
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (2)

  • 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.

    PMID: 33201202DERIVED

  • 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.

    PMID: 30704508DERIVED

MeSH Terms

Conditions

EmergenciesPulmonary Edema

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yonathan Freund, Doctor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

September 25, 2018

Study Start

December 10, 2018

Primary Completion

November 12, 2019

Study Completion

November 12, 2019

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)