REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
NCT02880163
Exsanguinating Hemorrhage, Exsanguination
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT07817966
Hemorrhagic shock from severe bleeding is a leading cause of preventable death in trauma patients. Intravenous (IV) fluid resuscitation is essential for stabilizing blood pressure and organ perfusion, but administering too much or too little fluid can cause severe complications. Only about half of hemodynamically unstable patients show an increase in cardiac output after receiving fluids. Emergency physicians often use bedside ultrasound to measure respiratory changes in the inferior vena cava (IVC), known as the IVC collapsibility index (IVC-CI), to predict whether a patient will benefit from fluids. However, obtaining clear IVC views can be difficult or impossible in trauma patients due to abdominal pain, obesity, or abdominal injuries. Evaluating the subclavian vein (SCV) under the collarbone provides a potential alternative window.
The main purpose of this study is to compare the diagnostic accuracy of the subclavian vein collapsibility index (SCV-CI) against the inferior vena cava collapsibility index (IVC-CI) for predicting fluid responsiveness in adult trauma patients presenting with hemorrhagic shock.
Eligible adult trauma patients with hemorrhagic shock will undergo rapid bedside point-of-care ultrasound upon presentation to the emergency department. Physicians will measure respiratory diameter variations in both the subclavian vein and inferior vena cava. Patients will then receive a standardized fluid challenge of 10 mL/kg intravenous balanced crystalloid solution over 10 to 15 minutes as part of resuscitation. Fluid responsiveness will be assessed by measuring changes in blood flow through the neck using carotid artery Doppler ultrasound before and 5 to 10 minutes after the fluid challenge. The study will determine whether subclavian vein ultrasound offers comparable diagnostic performance and greater feasibility compared to inferior vena cava ultrasound in emergency trauma resuscitation.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 minutes post-fluid challenge
The area under the receiver operating characteristic curve (AUC-ROC) will be calculated to determine the diagnostic accuracy of baseline SCV-CI for predicting fluid responsiveness. Fluid responsiveness is defined as an increase of ≥ 15% in carotid artery velocity time integral (Carotid VTI) following a 10 mL/kg crystalloid bolus. AUC values range from 0.5 (no discriminative ability) to 1.0 (perfect diagnostic accuracy).
Assiut University
Other
Comparison of Inferior Vena Cava Versus Subclavian Vein Collapsibility Indices for Prediction of Fluid Responsiveness in Adult Trauma Patients Presenting With Hemorrhagic Shock: A Prospective Comparative Cohort Study
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