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

NCT03683212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2020-07-02

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yonathan Freund, Doctor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-11-12
Completion
2019-11-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683212 on ClinicalTrials.gov