Early Detection of At-risk Septic Patients
ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Southampton NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Differential diagnosis which includes infection
Change in the quick Sequential Organ Failure Assessment (qSOFA) ≥2 or National Early Warning Score 2 (NEWS2) score ≥5
Aged ≥18 years
Disqualifiers
Traumatic injury
Rockwood frailty score ≥6
Critical care therapy previously believed to not be in patient's best interests
Advanced directive refusing critical care therapies.
Trial population
Adult patients presenting to the Emergency Department with their illness possibly caused by sepsis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measuring tissue oxygenation
Diagnostic testMeasuring oxygen content of arteries, capillaries and veins
Procalcitonin
Diagnostic testBlood test
Mid-regional proadrenomedullin
Diagnostic testBlood test looking at inflammation in the body
Hand-held video microscope
Diagnostic testA handheld video microscope that looks at blood flow through the capillaries of the tongue
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Patients presenting to the Emergency Department with suspected sepsis4 interventions
Trial outcomes
Primary outcomes
1
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..
Time frame
Up to 4 hours (from baseline); 28 days (follow-up)Secondary outcomes
1
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 %.
Time frame
Up to 4 hours (from baseline); 28 days (follow-up)2
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.
Time frame
Up to 4 hours (from baseline); 28 days (follow-up)3
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.
Time frame
Up to 4 hours (from baseline); 28 days (follow-up)4
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
Time frame
Up to 4 hours (from baseline); 28 days (follow-up)Sponsors and contacts
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Source ClinicalTrials.gov