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

24 septembre 2026 mis à jour par: Sabrin Salman Ahmed, Assiut University

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

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.

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Estimé)

300

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Early Hemodynamic Deterioration
Délai: Up to 24 hours

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 octobre 2027

Achèvement de l'étude (Estimé)

1 novembre 2027

Dates d'inscription aux études

Première soumission

24 septembre 2026

Première soumission répondant aux critères de contrôle qualité

24 septembre 2026

Première publication (Réel)

30 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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