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NCT07850427

Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Severe traumatic injury involving multiple body regions (polytrauma) carries a high risk of rapid bleeding, tissue hypoperfusion, and circulatory collapse. In the emergency setting, standard vital signs such as blood pressure and heart rate alone may not detect impending circulatory failure until significant deterioration has already occurred. The purpose of this prospective observational cohort study is to develop and internally validate a bedside clinical prediction model that identifies adult polytrauma patients at risk of early hemodynamic deterioration within 24 hours of arrival at the Emergency Department of Assiut University Hospital. Eligible adult patients presenting with acute trauma across at least two major body regions within 6 hours of injury will receive standard clinical evaluation and trauma resuscitation. Alongside routine care, researchers will record baseline predictor variables during initial evaluation, including: * Shock Index, calculated from heart rate and systolic blood pressure. * Inferior vena cava (IVC) respiratory collapsibility assessed via non-invasive bedside point-of-care ultrasound. * Initial blood gas and biochemical markers, including blood lactate concentration and base deficit. * Baseline neurological status using the Glasgow Coma Scale (GCS) and patient age. Participants will be followed for 24 hours to monitor for hemodynamic deterioration, defined as persistent or recurrent hypotension, the need for vasopressor or inotropic medications, major blood transfusion (at least 4 units of packed red blood cells), emergency surgical or interventional procedures to control bleeding, or trauma-related circulatory collapse death. The gathered data will be analyzed according to TRIPOD guidelines to create a multimodal risk tool that can assist emergency clinicians in recognizing high-risk trauma patients early.

Official title: Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients: A Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-10

Completion Date

2027-11

Last Updated

2026-09-30

Healthy Volunteers

Not specified

Conditions

Multiple Trauma Polytrauma Hemodynamic Instability Traumatic Shock Hemorrhage

Inclusion Criteria: * Age 18 years or older. * Acute traumatic injury involving at least two distinct predefined major anatomical body regions. * Presentation to the Emergency Department within 6 hours of injury. * Injuries requiring hospital-level trauma evaluation or management (operational definition of polytrauma). * Ability to obtain baseline predictor assessments (heart rate and systolic blood pressure for Shock Index, initial serum lactate, initial base deficit, and attempted point-of-care inferior vena cava ultrasound) as early as clinically feasible after ED arrival. * Informed consent obtained according to institutional and ethical requirements (from the patient or legally authorized representative). * Note: Hemodynamic stability at ED arrival is not required; patients presenting with hypotension (SBP \<90 mmHg), elevated Shock Index, or clinical shock remain eligible provided baseline predictor measurements can be obtained. Exclusion Criteria: * Isolated trauma involving only one anatomical body region. * Age younger than 18 years. * Pregnancy. * Invasive mechanical ventilation initiated prior to baseline inferior vena cava (IVC) assessment. * Known severe pre-existing cardiac dysfunction likely to substantially alter IVC respiratory dynamics (e.g., severe right heart failure, significant tricuspid regurgitation). * Significant chronic hepatic dysfunction likely to substantially interfere with baseline serum lactate clearance and interpretation. * Traumatic obstructive shock identified before baseline assessment (e.g., tension pneumothorax, cardiac tamponade) and resolved prior to obtaining measurements. * Transfer from an outside facility following substantial resuscitation (prior blood-product administration, vasopressor therapy, emergent surgery, or interventional radiology). * Inability to obtain baseline predictor measurements within the initial assessment window due to immediate priority of life-saving resuscitative procedures. * Missing baseline clinical or laboratory parameters preventing calculation of the primary prediction model. * Note: Inability to obtain an adequate IVC acoustic window alone is recorded as an ultrasound feasibility failure and does not exclude the patient.

Clinical Research Directory

Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients

Summary

Key Details

Conditions

Eligibility Criteria