Early Detection of At-risk Septic Patients

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

• Differences in tissue oxygenation [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]

Secondary outcome measures (7)

• Baseline of tissue oxygenation [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]
• Difference in blood flow of the micro-circulation (microvascular flow index) [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]
• Difference in blood flow of the micro-circulation (perfused vessel density) [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]
• Difference in blood lactate levels [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]
• Difference in blood tests (MR-proADM) [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]
• Difference in blood tests (Procalcitonin) [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]
• Correlation of extra investigations with standard patient outcomes [Time frame: Up to 4 hours (from baseline); 28 days (follow-up)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• University Hospital Southampton NHS Foundation Trust — Southampton

Publications

• Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Fr PMID 30772908
• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, J PMID 34605781
• Parrott F. Length of stay , survival and organ support of admissions with septic shock to adult , general critical care units in England , Wales and Northern Ireland. 2014.
• Liu Z, Meng Z, Li Y, Zhao J, Wu S, Gou S, Wu H. Prognostic accuracy of the serum lactate level, the SOFA score and the qSOFA score for mortality among adults with Sepsis. Scand J Trauma Resusc Emerg Med. 2019 Apr 30;27(1):51. doi: 10.1186/s13049-019-0609-3. PMID 31039813
• Sepsis: recognition, diagnosis and early management: (c) NICE (2017) Sepsis: recognition, diagnosis and early management. BJU Int. 2018 Apr;121(4):497-514. doi: 10.1111/bju.14179. No abstract available. PMID 29603898
• Jones S, Moulton C, Swift S, Molyneux P, Black S, Mason N, Oakley R, Mann C. Association between delays to patient admission from the emergency department and all-cause 30-day mortality. Emerg Med J. 2022 Mar;39(3):168-173. doi: 10.1136/emermed-2021-211572. Epub 2022 Jan 18. PMID 35042695
• 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. PMID 26468696
• NHS Digital. Hospital Accident & Emergency Activity 2021-2022. 2022.

Identifiers

NCT: NCT06253325 · CRI0436

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗