Early Detection of At-risk Septic Patients

Recruiting

• Conditions: Sepsis
• Interventions: Diagnostic Test: Measuring tissue oxygenation; Diagnostic Test: Procalcitonin; Diagnostic Test: Mid-regional proadrenomedullin; Diagnostic Test: Hand-held video microscope

• Registration Number: NCT06253325
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2024-01-08
• Study Start: 2024-01-12
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-08-06
• Study Completion: 2025-08-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients presenting to the Emergency Department with suspected sepsis	Procalcitonin	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
Patients presenting to the Emergency Department with suspected sepsis	Mid-regional proadrenomedullin	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
Patients presenting to the Emergency Department with suspected sepsis	Measuring tissue oxygenation	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
Patients presenting to the Emergency Department with suspected sepsis	Hand-held video microscope	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

Primary Outcome Measures

Name	Time	Method
Differences in tissue oxygenation	Up to 4 hours (from baseline); 28 days (follow-up)	The difference in tissue oxygen saturation (StO2) during the vascular occlusion test in the Emergency Department between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured in % change per second..

Secondary Outcome Measures

Name	Time	Method
Baseline of tissue oxygenation	Up to 4 hours (from baseline); 28 days (follow-up)	The difference in tissue oxygen saturation (StO2) at baseline in the Emergency Department between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured in %.
Difference in blood flow of the micro-circulation (microvascular flow index)	Up to 4 hours (from baseline); 28 days (follow-up)	Differences in the flow of blood through small blood vessels underneath the tongue between the difference between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured by the Microvascular Flow Index (arbitrary units) which is a validated measurement assessing micro-circulatory flow.
Difference in blood lactate levels	Up to 4 hours (from baseline); 28 days (follow-up)	The difference in the blood tests of lactate between septic patients who need critical care treatment (CCT) compared to patients requiring ward care
Difference in blood flow of the micro-circulation (perfused vessel density)	Up to 4 hours (from baseline); 28 days (follow-up)	Differences in the flow of blood through small blood vessels underneath the tongue between the difference between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured by the perfused vessel density (measured in mm/mm2) which is a validated measurement assessing micro-circulatory flow.
Difference in blood tests (MR-proADM)	Up to 4 hours (from baseline); 28 days (follow-up)	The difference in the blood tests of MR-proADM between septic patients who need critical care treatment (CCT) compared to patients requiring ward care
Difference in blood tests (Procalcitonin)	Up to 4 hours (from baseline); 28 days (follow-up)	The difference in the blood tests of Procalcitonin (PCT) between septic patients who need critical care treatment (CCT) compared to patients requiring ward care
Correlation of extra investigations with standard patient outcomes	Up to 4 hours (from baseline); 28 days (follow-up)	Looking at whether tissue oxygenation, buccal microcirculation (blood flow under the tongue) and biomarkers and correlation with clinical outcomes such as organ failure (SOFA) scores, 28-day hospital mortality, and length of hospital and ICU stay.

Trial Locations

Locations (1)

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, Hampshire, United Kingdom