Early Detection of At-risk Septic Patients (MMICS)

University Hospital Southampton NHS Foundation Trust

Status: Enrolling

Conditions: Sepsis

Treatments: Diagnostic Test: Procalcitonin; Diagnostic Test: Measuring tissue oxygenation; Diagnostic Test: Hand-held video microscope; Diagnostic Test: Mid-regional proadrenomedullin

Study type: Observational

Funder types: Other

Identifiers

NCT06253325

CRI0436

Details and patient eligibility

About

The purpose of this study is to determine whether additional investigations used in other parts of healthcare can be used in the Emergency Department to identify critically ill patients quicker than usual care.

Full description

The investigators intend to recruit 56 patients with suspected sepsis who attend the Emergency Department. The investigators want to use a device to monitor tissue oxygen levels when they first come into the Emergency Department as well as the change in tissue oxygen levels when a tourniquet is applied for 3 minutes. The investigators will take novel blood tests when the patient is having their routine bloods. Finally, the investigators will use a special camera to take specialised pictures of the small blood vessels under the tongue which will show blood flow through these vessels. The investigators will follow the recruited patients and determine if our extra data is better at determining who needs critical care. A significant proportion of patients may be too unwell or too distressed to consent to be part of this study. At the earliest opportunity, the investigators will ask patients when they have been stabilised and are able to give consent. If they say no, they will be removed from the study and their care will not be affected by this decision.

The results could help us identify septic shock as early as possible so that these unwell patients are identified early and get the correct treatment they need. This could mean starting advanced treatments usually found in the Intensive Care Unit very early on in a patient's journey.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Patients presenting to the Emergency Department with suspected sepsis

Description:

Patients who present with potential sepsis. This is characterised by their illness suspected to be from an infection and significantly unwell defined by one of two scoring systems, either the National Early Warning Score or quick Sequential Organ Failure Assessment

Treatment:

Diagnostic Test: Mid-regional proadrenomedullin

Diagnostic Test: Hand-held video microscope

Diagnostic Test: Measuring tissue oxygenation

Diagnostic Test: Procalcitonin