NCT03683212

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2018-12-10
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2018-09-25
• Last updated: 2020-07-02

Locations

1 site across 1 country: France