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Effect of the 1-hour Sepsis Bundle on In-hospital Mortality in Patients With Sepsis in the Emergency Department

NCT05273034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 873

Last updated 2024-02-26

No results posted yet for this study

Summary

Reducing the mortality and morbidity of sepsis is a worldwide priority for almost 20 years. Since an observational study in the NY state, which reported in-hospital mortality increased, associated with each supplemental hour to complete the sepsis bundle, SSC guidelines have decided in 2018 to recommend a short timeframe of 1-h to complete the sepsis bundle. This new recommendation is vividly debated due to a lack of evidences of its relevance. No trial has ever studied a sepsis intervention when applied as early as Emergency Department ED triage (newly recommended 1-h sepsis bundle consider time zero as time of ED triage).

The aim of this trial is to demonstrate that the early implementation at ED triage of the 1-hour bundle by ED physicians improves in-hospital mortality in patients with sepsis, and therefore provides the required robust evidence for the SSC guidance to enhance physicians and stakeholder adherence.

This is a superiority, international multicenter, open trial with a stepped wedge randomisation.

All centers will recruit adult emergency patients with suspicion of sepsis as defined by a suspicion of infection and suspicion of life threatening organ dysfunction (quick SOFA or SOFA ≥ 2, hypotension or hyperlactatemia).

According to the center period, the management of sepsis patients will be based either following the current recommended 1-hour sepsis bundle (intervention group) or at the discretion of the treating ED physician as in current routine practice (control group). There is no intervention that is "added" by the research.

Conditions

Interventions

PROCEDURE

1-hour sepsis bundle

The sepsis management will be delivered in a timely manner within 60 minutes of ED triage including * usual test and treatment * blood culture * lactate measurement * broad spectrum antibiotics * In case of hypotension or lactate \> 4, rapid administration of 30ml/kg crystalloid fluid resuscitation will be mandated * In case of initial elevated lactate (\> 2 mmol/l), a second lactate measurement should be done after initial fluid resuscitation.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yonathan FREUND, PU-PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2023-10-13
Completion
2023-10-13

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT05273034 on ClinicalTrials.gov