NCT06253325

Early Detection of At-risk Septic Patients

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measuring tissue oxygenation	Measuring oxygen content of arteries, capillaries and veins
DIAGNOSTIC_TEST	Procalcitonin	Blood test
DIAGNOSTIC_TEST	Mid-regional proadrenomedullin	Blood test looking at inflammation in the body
DIAGNOSTIC_TEST	Hand-held video microscope	A handheld video microscope that looks at blood flow through the capillaries of the tongue

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-08-06
• Completion: 2025-08-06
• First posted: 2024-02-12
• Last updated: 2024-12-02

Locations

1 site across 1 country: United Kingdom