Early Detection of At-risk Septic Patients

Sepsis Clinical Trial

— MMICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253325
• Other study ID #: CRI0436
• Status: Recruiting
• Start date: January 12, 2024
• Est. completion date: August 6, 2024

Study information

• Verified date: February 2024
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: James N Ward, BM
• Phone: +447881967336
• Email: wardj[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 6, 2024
• Est. primary completion date: August 6, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (33)

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Linder A, Arnold R, Boyd JH, Zindovic M, Zindovic I, Lange A, Paulsson M, Nyberg P, Russell JA, Pritchard D, Christensson B, Akesson P. Heparin-Binding Protein Measurement Improves the Prediction of Severe Infection With Organ Dysfunction in the Emergency Department. Crit Care Med. 2015 Nov;43(11):2378-86. doi: 10.1097/CCM.0000000000001265. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in tissue oxygenation	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..	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Baseline of tissue oxygenation	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 %.	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Difference in blood flow of the micro-circulation (microvascular flow index)	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.	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Difference in blood flow of the micro-circulation (perfused vessel density)	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.	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Difference in blood lactate levels	The difference in the blood tests of lactate between septic patients who need critical care treatment (CCT) compared to patients requiring ward care	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Difference in blood tests (MR-proADM)	The difference in the blood tests of MR-proADM between septic patients who need critical care treatment (CCT) compared to patients requiring ward care	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Difference in blood tests (Procalcitonin)	The difference in the blood tests of Procalcitonin (PCT) between septic patients who need critical care treatment (CCT) compared to patients requiring ward care	Up to 4 hours (from baseline); 28 days (follow-up)
Secondary	Correlation of extra investigations with standard patient outcomes	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.	Up to 4 hours (from baseline); 28 days (follow-up)