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

Not Applicable

Completed

• Conditions: Acute Heart Failure
• Interventions: Procedure: Early intensive care bundle

• Registration Number: NCT03683212
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2018-12-10
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention period : early and comprehensive care bundle	Early intensive care bundle	-

Primary Outcome Measures

Name	Time	Method
Number of days alive and out of hospital	30 days	Number of days alive and out of hospital

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Emergency department Hospital Pitié-Salpêtrière; 🇫🇷 Paris, France