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

NCT05731349 | Completed DMC

• 1 other identifier: Project No. 19201161
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Sepsis; National Early Warning Score; Surviving Sepsis Campaign Hour-1 Bundle; Emergency Department; Implementation Sciences

Outcome Measures

Primary Outcomes (1)

• All-cause 30-day mortality (in full-scale stepped wedge RCT)

  The number of patients who die over 30 days

  30 days

Other Outcomes (10)

• All-cause in-hospital mortality (in full-scale stepped wedge RCT)

  From the date of recruitment until the date of death from any cause or date of hospital discharge, whichever comes first, assessed up to 90 days

• All-cause 90-day mortality (in full-scale stepped wedge RCT)

  90 days

• Sepsis-related in-hospital mortality (in full-scale stepped wedge RCT)

  From the date of recruitment until the date of death from sepsis or date of hospital discharge, whichever comes first, assessed up to 90 days

Study Arms (2)

NEWS-1 care

EXPERIMENTAL

During the interventional period, the 2018 Sepsis Hour-1 Bundle will be initiated in the ED if NEWS2 score ≥ 5.

Other: 2018 Surviving Sepsis Campaign Hour-1 Bundle

Standard care

NO INTERVENTION

During the standard care period, emergency physicians will assess the patients based on history, physical examination, laboratory tests, chest radiography or other imaging studies, and will offer treatment based on clinical expertise, intuition, and local or international guidelines

Interventions

2018 Surviving Sepsis Campaign Hour-1 Bundle OTHER

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

NEWS-1 care

Eligibility Criteria

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

You may qualify if:

• ED patients aged ≥ 18 years who fulfil ALL of the following criteria:
• a clinical diagnosis of infection made by the treating emergency physicians
• require hospital admission
• a NEWS2 ≥ 5

You may not qualify if:

• age \< 18 years
• currently pregnant
• neutropenic or post-chemotherapy fever, for which ED protocols for early antibiotics apply
• an advanced directive with a ceiling-of-care
• refusal of consent/pre-existing mental illness rendering consent impossible
• refusal of hospitalization

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Tuen Mun Hospital: collaborator

Study Sites (4)

Accident and Emergency Department, Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Accident and Emergency Department, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Accident and Emergency Department, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Accident and Emergency Department, Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Lam RPK, Hung KKC, Lui CT, Kwok WS, Lam WWT, Lau EHY, Sridhar S, Ng PYT, Cheng CH, Tsang TC, Tsui MSH, Graham CA, Rainer TH. 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. BMJ Open. 2024 Feb 1;14(2):e080676. doi: 10.1136/bmjopen-2023-080676.

  PMID: 38307529 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Pui Kin Lam, MBBS, MPH

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not feasible given the study design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine Practice, Department of Emergency Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine

Model Details: Stepped-wedge, cluster-randomized trial

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 16, 2023
• Study Start: April 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 9 months after publication of the main results
• Access Criteria: De-identified study data will be available on reasonable request 9 months after publication of the main results, subject to the additional research ethics approval on data sharing.

Locations

HK (4)