Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department

Summary

The goal of this pilot clinical trial is to determine the feasibility of conducting a fully powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided by early warning score in adult emergency department (ED) patients who have infection. The main questions it aims to answer are:

* Is it feasible to execute the trial procedure and fulfill the progression criteria to a full-scale trial?
* Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of adult ED patients with a clinical diagnosis of infection and a National Early Warning Score 2 (NEWS2) equal to or greater than 5?
* What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle in the ED settings?

Participants will receive the following SSC Hour-1 Bundle care during the intervention period:

* Blood lactate level measurement
* Blood cultures collection before administering antibiotics
* Broad-spectrum antibiotics
* Intravenous fluid
* Vasopressors if the blood pressure remains low during or after fluid replacement to maintain the mean arterial blood pressure equal to or greater than 65 mmHg

Researchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to or greater than 5 and patients who receive standard treatment based on clinical judgement to see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult ED patients with infection.

Conditions

• Sepsis
• Septic Shock

Interventions

OTHER

2018 Surviving Sepsis Campaign Hour-1 Bundle

1. Measure lactate 2. Obtain blood cultures before administering antibiotics 3. Administer broad-spectrum antibiotics based on local guidelines 4. Begin fluid resuscitation with up to 30 mL/kg crystalloid for hypotension or lactate level ≥ 4 mmol/L. 5. Apply vasopressors if hypotensive during or after fluid resuscitation to maintain the MAP ≥ 65 mm Hg

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• Pamela Youde Nethersole Eastern Hospital

  collaborator OTHER

• Prince of Wales Hospital, Shatin, Hong Kong

  collaborator OTHER

• Tuen Mun Hospital

  collaborator OTHER_GOV

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Pui Kin Lam, MBBS, MPH · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-01

Primary Completion

2024-05-31

Completion

2024-05-31

Countries

• Hong Kong

Study Locations