Identifying at-risk septic patients in the Emergency Department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit 56 patients suspected of having sepsis upon arrival at the Emergency Department. The investigators will utilize a device to monitor tissue oxygen levels and assess changes when a tourniquet is applied. Additionally, novel blood tests will be conducted alongside routine blood work, and specialized imaging will be performed to evaluate blood flow in small vessels under the tongue. The goal is to determine if this additional data can more effectively identify patients who require critical care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Differential diagnosis which includes infection
2. Change in the quick Sequential Organ Failure Assessment (qSOFA) ≥2 or National Early Warning Score 2 (NEWS2) score ≥5
3. Aged ≥18 years

Exclusion Criteria:

1. Traumatic injury
2. Rockwood frailty score ≥6
3. Critical care therapy previously believed to not be in patient's best interests
4. Critical care therapies-initiated pre-hospital. Critical care therapies defined as:

   4.1 Mechanical ventilation 4.2 Vasopressor/inotrope therapy 4.3 Sedation or a general anaesthetic 4.4 Pre-hospital transfusion of blood products 4.5 Extra-corporeal support
5. Advanced directive refusing critical care therapies.
6. Acute cardiac failure
7. Active gastrointestinal bleed
8. Massive pulmonary embolism
9. ICU admission declined by critical care team
10. Treated in an acute hospital \<6 hours before presentation to the Emergency Department

Where it's running

• University Hospital Southampton NHS Foundation Trust
  Southampton, Hampshire, United Kingdom Recruiting

Study contacts

• Principal investigator: James N Ward, BM — University Hospital Southampton NHS Foundation Trust
• Study coordinator: James N Ward, BM
• Email: wardj@doctors.org.uk
• Phone: +447881967336

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.