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

NCT05273034 | Completed

• 2 other identifiers: APHP211023IDRCB 2021-A01937-34
• Study Type: interventional
• Target: 873
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Keywords

Sepsis; 1-hour sepsis bundle; Emergency department

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Safety Issue ? : Yes / No

  truncated at day 28

Secondary Outcomes (7)

• Amount of fluid resuscitation

  in the first 24 hours

• Acute heart failure

  During the first 24 hours

• SOFA score

  Up to 3 days

• ICU length of stay

  Up to 3 days

• Total number of days under mechanical ventilation, renal replacement therapy, and vasopressor-free

  within 28 days

Study Arms (2)

1-h sepsis bundle

EXPERIMENTAL

Procedure: 1-hour sepsis bundle

Current practice

NO INTERVENTION

Interventions

1-hour sepsis bundle PROCEDURE

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.

1-h sepsis bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ED adult patients, with suspected infection
• AND at least one of the following:
• Serum lactate \> 2.0 mmol/l
• Systolic blood pressure \< 90 mmHg
• Suspicion of sepsis as defined by the SEPSIS-3 International consensus: life threatening organ dysfunction identified by a SOFA score of 2 at least or a quick SOFA score of 2 at least (altered consciousness, systolic blood pressure \< 100 mmHg, respiratory rate \> 22)

You may not qualify if:

• Patient living in assisted-living home or nursing home or palliative center
• Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
• Anticipated life expectancy \< 3 months or "do not resuscitate" order
• Known acute heart failure
• No social security
• Pregnancy and breastfeeding
• Prisoners
• Participation in another interventional trial (RIPH 1 et 2)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Yonathan FREUND, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 10, 2022
• Study Start: June 13, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

FR (1)