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

NCT07850427 | Not Yet Recruiting

• 1 other identifier: Polytrauma Deterioration Score
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Trauma; Polytrauma; Hemodynamic Instability; Traumatic Shock; Hemorrhage

Keywords

Shock Index; Inferior Vena Cava Collapsibility; Point-of-Care Ultrasound; Serum Lactate; Base Deficit; Clinical Prediction Model; Emergency Department; TRIPOD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Early Hemodynamic Deterioration

  Number of participants experiencing early hemodynamic deterioration, defined as a single composite binary endpoint if a participant meets at least one of the following criteria: systolic blood pressure \< 90 mmHg persisting for at least 15 minutes despite initial resuscitation, initiation of vasopressor or inotropic support, transfusion of at least 4 units of packed red blood cells, emergency definitive surgical or interventional radiological hemorrhage-control procedure, or trauma-related circulatory collapse death.

  Up to 24 hours

Study Arms (1)

Adult Polytrauma Cohort

Consecutive adult polytrauma patients aged 18 years or older presenting to the Emergency Department within 6 hours of acute injury involving at least two distinct major anatomical regions. Participants receive standard trauma evaluation and resuscitation alongside baseline observational predictor assessments, including Shock Index (heart rate/systolic blood pressure), point-of-care ultrasound measurement of inferior vena cava (IVC) respiratory collapsibility, initial serum lactate, initial base deficit from blood gas analysis, age, and Glasgow Coma Scale (GCS). Participants are followed for 24 hours to evaluate for early hemodynamic deterioration.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult polytrauma patients aged 18 years or older presenting to the Emergency Department of Assiut University Hospital within 6 hours of sustaining acute traumatic injuries involving at least two distinct predefined major anatomical body regions requiring hospital-level trauma evaluation or management.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Multiple Trauma; Shock, Traumatic; Hemorrhage; Emergencies

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09