Sepsis Clinical Trial
— NEWS-1-TRIPSOfficial title:
Early Sepsis Care With the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the Emergency Department: A Hybrid Type 1 Effectiveness-Implementation Pilot Stepped Wedge Randomised Controlled Trial (NEWS-1 Trial Pilot Study)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Accident and Emergency Department, Pamela Youde Nethersole Eastern Hospital | Hong Kong | |
Hong Kong | Accident and Emergency Department, Prince of Wales Hospital | Hong Kong | |
Hong Kong | Accident and Emergency Department, Queen Mary Hospital | Hong Kong | |
Hong Kong | Accident and Emergency Department, Tuen Mun Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Pamela Youde Nethersole Eastern Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, Tuen Mun Hospital |
Hong Kong,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | All-cause in-hospital mortality (in full-scale stepped wedge RCT) | The number of patients who die during the index hospitalization | 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 | |
Other | All-cause 90-day mortality (in full-scale stepped wedge RCT) | The number of patients who die over 90 days | 90 days | |
Other | Sepsis-related in-hospital mortality (in full-scale stepped wedge RCT) | The number of patients who die during the index hospitalization because of sepsis, as judged by an independent emergency physician and an infectious disease specialist based on review of clinical notes and autopsy findings, if available | 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 | |
Other | Intensive care unit admission (in full-scale stepped wedge RCT) | Number of participants who require intensive care unit admission during the index hospitalization | From the date of recruitment until the date of first documented intensive care unit admission or date of hospital discharge or date of death, whichever comes first, assessed up to 90 days | |
Other | Ventilator-free days over 30 days (in full-scale stepped wedge RCT) | The number of ventilator-free days over 30 days after recruitment | Over 30 days following recruitment | |
Other | The need for renal replacement therapy (in full-scale stepped wedge RCT) | The number of patients who require renal replacement therapy during the index hospitalization that is not due to pre-existing renal failure | From the date of recruitment until the date of first documented renal replacement therapy or date of hospital discharge or date of death, whichever comes first, assessed up to 90 days | |
Other | The total length of stay in the emergency department (in full-scale stepped wedge RCT) | The total number of hour of patient stay in the emergency department | From the time of emergency department registration to the time of check out from the emergency department or time of death in the emergency department, whichever comes first, assessed up to 7 days | |
Other | The total length of stay in the intensive care unit (in full-scale stepped wedge RCT) | The total number of days of patient stay in the intensive care unit | From the date of intensive care unit admission until the date of discharge from the intensive care unit or date of death, whichever comes first, assessed up to 90 days | |
Other | The total length of stay in the general ward (in full-scale stepped wedge RCT) | The total number of days of patient stay in the general ward | From the date of hospital admission to general ward until the date of hospital discharge or date of transfer out of general ward or date of death, whichever comes first, assessed up to 90 days | |
Other | The time to surgery (in full-scale stepped wedge RCT) | The number of hours from ED registration to the first surgery for cases who receive surgery during the index hospitalization | From the of emergency department registration until the first documented time of surgery or time of hospital discharge or time of death, whichever comes first, assessed up to 90 days | |
Primary | All-cause 30-day mortality (in full-scale stepped wedge RCT) | The number of patients who die over 30 days | 30 days |
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