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NCT05731349: NEWS-1-TRIPS

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

Completed NA Last updated 22 July 2024
What this trial tests

NA trial testing 2018 Surviving Sepsis Campaign Hour-1 Bundle in Sepsis in 200 participants. Completed in 31 May 2024.

Timeline
1 April 2023
Primary endpoint
31 May 2024
31 May 2024

Quick facts

Lead sponsorThe University of Hong Kong
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date1 April 2023
Primary completion31 May 2024
Estimated completion31 May 2024
Sites4 locations across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Early sepsis care with the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the emergency department: hybrid type 1 effectiveness-implementation pilot stepped wedge randomised controlled trial (NEWS-1 TRIPS) protocol.
    Lam RPK, Hung KKC, Lui CT, Kwok WS, et al · · 2024 · cited 3× · PMID 38307529 · DOI 10.1136/bmjopen-2023-080676

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Other recruiting trials for Sepsis

Currently open trials in the same condition.

Other The University of Hong Kong trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05731349.

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