Short summary

Shock is a critical condition which can cause severe multi-organ failure and death if not treated effectively. It can be difficult to identify condition and causes, especially in the early stages. Knowledge on current treatment practice in patients with shock presenting to Danish Emergency Departments are lacking. This study aims to investigate patients with shock, including mortality, treatment, interventions and how these might differ for patients not eligible for admittance to intensive care

Rationale

Background: Undifferentiated shock occurs in about 0.4% of all patient contacts in Danish Emergency Departments (ED). A key feature of shock is the hemodynamic collapse with hypotension, failing widespread tissue perfusion leading to multi-organ failure and possibly cardiac arrest and death.3 Patients affected by shock have a high mortality risk, but most of these patients are treated in the ED and only about 21% of them are transferred to the Intensive Care Unit (ICU). Shock occurrence has also been increasing in Denmark, most likely due to an aging population. As shock is a time critical condition, it requires early intervention and treatment to managed effectively. Treatment algorithms vary widely across different aetiologies and encompasses protocols or recommendations such as Advanced Trauma Life Support, Advanced Life Support8 and Surviving Sepsis Campaign. Even though these recommendations are widely known and expected to be followed, the adherence rate is low and could possibly put patients at risk. Shock is commonly divided into different classifications, with the most widespread being the hypovolemic, distributive, cardiogenic or obstructive terminology. In the early stages of shock, it can be difficult to interpret which type of shock the patient suffers from, including identifying the correct underlying cause. Additionally, trauma patients can present with multiple shock causes while patients suspected of septic shock might be due to non-septic causes while not initially identified as such. Shock outcomes and underlying aetiology in Danish EDs has previously been described, but knowledge on how the condition is treated is lacking. Delay of early intervention, or excessive use of treatments such as fluid therapy, can lead to adverse outcomes and increased mortality or morbidity. As some patients are never admitted to the ICU, either due to quick stabilization or limited goals of care, it is essential to review current treatment standards for these patients and investigate if expected recommendations are followed. Also, patients might not be sufficiently stabilized due to misclassification or suspicion of the underlying causes. A thorough understanding of current treatment practises could identify relevant areas for quality improvements or research areas for future treatment implementations. Aim: To investigate the mortality of shock, how the patients are treated for the condition during their admittance to Danish EDs and how the treatment and interventions differ between patients who are, and aren't, ICU eligible.

Description of the cohort

3.1 Setting and patient population This is an observational cohort study assessing patients admitted to either the ED at Odense University Hospital, Esbjerg Hospital and Lillebaelt Hospital, Kolding in the period from March 2022 to February 2024. Current organization of the EDs included in the study follows a hybrid model which includes a mix of both Emergency Medicine (EM) specialists and specialists from other specialties. Some EDs have 24/7 presence of an EM specialist, while others only have 24/7 presence some days during the month and others are without EM specialist coverage during late evening and night hours. Screening We will screen all patients ≥18 years of age who arrived at an ED at the participating hospitals for inclusion with either 1. At least one measurement of either systolic blood pressure (SBP) ≤100 mmHg or mean arterial pressure (MAP) ≤65 mmHg during the ED stays registered in the electronic medical records Or 2. Arriving as a trigger call team activation. Patients will be identified using their Personal Registration Number (PRN) which uniquely identifies each individual.16 Data will be extracted by a data manager from The Region of Southern Denmark, who is otherwise unrelated to the trial, prior to assessing inclusion and exclusion criteria. Patients arriving to the ED with registered trigger team activation will be assessed manually by chart review as these patients do not always have vital parameters registered that allow for electronic data extraction. Inclusion criteria 1. ≥18 years of age. 2. Hypotension defined as at least one measurement of SBP ≤ 100 mmHg or MAP ≤ 65 mmHg 3. ≥ 1 organ failure

Data and biological material

The primary outcome is 30-day all-cause mortality. Secondary outcomes and exploratory outcomes include all-cause in-hospital, 7-day and 90-day mortality, ED, ICU and hospital length of stay (LOS), ICU eligibility decision by non-ICU and ICU physicians including time of ICU consult, time from ED arrival to ICU consult, time from ICU consult to ICU arrival, time from ED arrival to ICU admittance, fluid therapy within 3, 6, and 24 hours, including volume, type and reason for administration, transfusion of red blood cells, thrombocytes and fresh frozen plasma, including volume, antibiotic usage, oxygen therapy including delivery type (e.g. binasal airway, continuous positive airway pressure (CPAP), non-invasive ventilation (NIV)), use of vasopressor and inotropy therapy, use of mechanical circulatory support (e.g. extracorporeal membrane oxygenation (ECMO)), use of invasive monitoring (arterial line for blood pressure, central venous catheter (CVC) for parameters such as central venous pressure (CVP)), use of needle decompression for tension pneumothorax, pericardiocentesis, emergency thoracotomy (e.g. resuscitative thoracotomy), finger thoracotomy, surgical pleural drainage, thoracocentesis, use of intraosseous access, use of central venous catheter, need for emergency surgery defined as surgery <24 hours from arrival. Data collection and storage All data are collected from the electronic medical record applicable for each trial site, including the Prehospital Patient Journal (PPJ), the Electronic Patient Journal (EPJ Syd), Critical Information System (CIS) including any medical record systems that are connected to these for functionality and data storage. Data will be partly collected using electronic data extraction through a data manager and partly from manual review of medical records. Data collection and storage are completed using a secure web-based software platform REDCap (Research Electronic Data Capture) hosted at University of Southern Denmark via Open Patient data Explorative Network OPEN and a secure SharePoint site hosted at The Region of Southern Denmark. Access is provided at an individual level with required multi-factor authentication. All access and data handling are logged on an individual level following European General Data Protection Regulation and Danish Data Protection Act. Large Language Model for identification and data extraction The study will use a Large Language Model (LLM) for data extraction of specific parameters. These parameters include fluid therapy type, volume and timing, contact to the ICU consultant and sub-sequent decision of ICU eligibility and/or acceptance of ICU admittance. The LLM will be developed prior to collection of these data points using previously build LLM platforms currently used for similar data identification and handling in other Danish research projects.

Collaborating researchers and departments

Department of Emergency Medicine and Research Unit for Emergency Medicine, Odense University Hospital

• Mikkel Brabrand, MD, PhD
• Annmarie Touborg Lassen, MD, PhD, DMSc

Department of Anaesthesiology and Intensive Care medicine Odense University Hospital

• Thomas Strøm, MD, PhD

Department of Emergency Medicine, Lillebaelt Hospital, Kolding

• Anne Friesgaard Christensen, MD, PhD

Department of Emergency Medicine, Hospital of Southwest Jutland, Esbjerg

• Peter Biesenbach, MD

Department of Clinical Biochemistry, Odense University Hospital

• Pernille Just Vinholt, MD, PhD

Department of Internal Medicine, Lillebaelt Hospital, Vejle

• Kirse Pernille Bock, MD