Identifying at-risk septic patients in the Emergency Department

An Observational Pilot Study for the Multi-Modality Risk Prediction and Early Identification of Critically Ill Septic Patients in the Emergency Department

This study is testing if new monitoring tools and blood tests can help doctors quickly find out which patients with suspected sepsis need critical care when they arrive at the Emergency Department.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Southampton NHS Foundation Trust (Academic / other)
• Locations: 1 site (Southampton, Hampshire)
• Trial ID: NCT06253325 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with suspected sepsis and specific clinical indicators of deterioration.

Not a fit: Patients with traumatic injuries, advanced directives refusing critical care, or those who have received critical care therapies prior to arrival may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier identification and treatment of septic shock, improving patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in early detection of sepsis using advanced monitoring techniques.

Eligibility criteria

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 this trial is running

Southampton, Hampshire

• 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

Conditions Sepsis