Clinical trial NCT06253325: Early Detection of At-risk Septic Patients
Official title: An Observational Pilot Study for the Multi-Modality Risk Prediction and Early Identification of Critically Ill Septic Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to the Emergency Department with their illness possibly caused by sepsis

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Differences in tissue oxygenation
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
Secondary outcomes:
measure: Baseline of tissue oxygenation
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
measure: Difference in blood flow of the micro-circulation (microvascular flow index)
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
measure: Difference in blood flow of the micro-circulation (perfused vessel density)
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
measure: Difference in blood lactate levels
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
measure: Difference in blood tests (MR-proADM)
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
measure: Difference in blood tests (Procalcitonin)
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
measure: Correlation of extra investigations with standard patient outcomes
timeFrame: Up to 4 hours (from baseline); 28 days (follow-up)
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Ahilanandan Dushianthan, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: James N Ward, BM
role: PRINCIPAL_INVESTIGATOR
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