Early Detection of At-risk Septic Patients

NCT06253325 | Recruiting

• 1 other identifier: CRI0436
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

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..

  Up to 4 hours (from baseline); 28 days (follow-up)

Secondary Outcomes (7)

• Baseline of tissue oxygenation

  Up to 4 hours (from baseline); 28 days (follow-up)

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

  Up to 4 hours (from baseline); 28 days (follow-up)

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

  Up to 4 hours (from baseline); 28 days (follow-up)

• Difference in blood lactate levels

  Up to 4 hours (from baseline); 28 days (follow-up)

• Difference in blood tests (MR-proADM)

  Up to 4 hours (from baseline); 28 days (follow-up)

Study Arms (1)

Patients presenting to the Emergency Department with suspected sepsis

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

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

Interventions

Measuring tissue oxygenation DIAGNOSTIC_TEST

Measuring oxygen content of arteries, capillaries and veins

Patients presenting to the Emergency Department with suspected sepsis

Procalcitonin DIAGNOSTIC_TEST

Blood test

Also known as: PCT

Patients presenting to the Emergency Department with suspected sepsis

Mid-regional proadrenomedullin DIAGNOSTIC_TEST

Blood test looking at inflammation in the body

Also known as: MR-proADM

Patients presenting to the Emergency Department with suspected sepsis

Hand-held video microscope DIAGNOSTIC_TEST

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

Patients presenting to the Emergency Department with suspected sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to the Emergency Department with their illness possibly caused by sepsis

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Related Publications (33)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Twenty millilitres of whole blood will be collected. Plasma will be separated by centrifugation and stored at -80 degrees celsius until further analysis

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahilanandan Dushianthan, PhD

  University Hospital Southampton NHS Foundation Trust

  STUDY DIRECTOR

• James N Ward, BM

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James N Ward, BM

CONTACT

+447881967336; wardj@doctors.org.uk

Ahilanandan Dushianthan, PhD

CONTACT

+447903943418; a.dushianthan@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 12, 2024
• Study Start: January 12, 2024
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication

Locations

GB (1)