Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06253325

Early Detection of At-risk Septic Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location status: Recruiting

Location contact

James N Ward, BM

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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:

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

  • Advanced directive refusing critical care therapies.
  • Acute cardiac failure
  • Active gastrointestinal bleed
  • Massive pulmonary embolism
  • ICU admission declined by critical care team
  • Treated in an acute hospital <6 hours before presentation to the Emergency Department

Treatment and study plan

Measuring tissue oxygenation

Diagnostic Test

Measuring oxygen content of arteries, capillaries and veins

procalcitonin

Diagnostic Test

Blood test

Other names: PCT

Mid-regional proadrenomedullin

Diagnostic Test

Blood test looking at inflammation in the body

Other names: MR-proADM

Hand-held video microscope

Diagnostic Test

A handheld video microscope that looks at blood flow through the capillaries of the tongue

Primary outcomes

  1. Differences in tissue oxygenation

    Time frame: 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 outcomes

  1. Baseline of tissue oxygenation

    Time frame: 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 %.

  2. Difference in blood flow of the micro-circulation (microvascular flow index)

    Time frame: 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.

  3. Difference in blood flow of the micro-circulation (perfused vessel density)

    Time frame: 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.

  4. Difference in blood lactate levels

    Time frame: 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

  5. Difference in blood tests (MR-proADM)

    Time frame: 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

  6. Difference in blood tests (Procalcitonin)

    Time frame: 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

  7. Correlation of extra investigations with standard patient outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahilanandan Dushianthan, PhD

CONTACT

[email protected]

+447903943418

James N Ward, BM

CONTACT

[email protected]

+447881967336

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: MMICS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.