At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Measuring tissue oxygenation (diagnostic test), Procalcitonin (diagnostic test), Mid-regional proadrenomedullin (diagnostic test), Hand-held video microscope (diagnostic test)
- How long the study runs
- Study runs about 19 months (dates as stated)
- About the drug or intervention
- Measuring tissue oxygenation — diagnostic test: Measuring oxygen content of arteries, capillaries and veins · Procalcitonin — diagnostic test: Blood test · Mid-regional proadrenomedullin — diagnostic test: Blood test looking at inflammation in the body · Hand-held video microscope — diagnostic test: A handheld video microscope that looks at blood flow through the capillaries of the tongue
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2024-01-12
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for sepsis
- • Clinical study - 60 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with sepsis
Where?
- • Southampton - University Hospital Southampton NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Traumatic injury
- ✗Rockwood frailty score ≥6
- ✗Critical care therapy previously believed to not be in patient's best interests
- ✗Critical care therapies-initiated pre-hospital. Critical care therapies defined as:
- ✗1 Mechanical ventilation 4.2 Vasopressor/inotrope therapy 4.3 Sedation or a general anaesthetic 4.4 Pre-hospital...
See the full criteria
Where Is This Study? (1 UK site)
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
How to Get in Touch
James N Ward, BM
Sponsor contactCONTACT
Ahilanandan Dushianthan, PhD
Sponsor contactCONTACT