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

NCT ID: NCT03683212

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2019-11-12

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention period : early and comprehensive care bundle

Group Type: EXPERIMENTAL

Early intensive care bundle

Intervention Type: PROCEDURE

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.

acute heart failure standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early intensive care bundle

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 Type: PROCEDURE

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yonathan Freund, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Emergency department Hospital Pitié-Salpêtrière

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33201202 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30704508 (View on PubMed)

Other Identifiers

2018-A01139-46

Identifier Type: OTHER

Identifier Source: secondary_id

K170918J

Identifier Type: -

Identifier Source: org_study_id