Evaluation of Resuscitation Markers in Trauma Patients

Study Overview
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Brief Summary
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Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients. This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.

Official Title
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Evaluation of Resuscitation Markers in Trauma Patients

Conditions
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Trauma, Hypovolemic Shock

Intervention / Treatment
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* Other: Blood Lactate
* Other: Blood Base Excess
* Other: Blood B-type Natriuretic Peptide
* Other: Blood Thromboelastometry (ROTEM)
* Other: Near-infrared spectroscopy
* Other: Sublingual videomicroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-hospital Priority 0 protocol activation: Glasgow coma scale < 14 Systolic blood pressure < 90 mmHg Respiratory rate < 10 or > 29 breaths per minute Absent peripheral pulses Pre-hospital Priority 1 protocol activation: All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee Flail chest Two or more proximal long-bone fractures Crushed, degloved or mangled extremity Amputation proximal to wrist and ankle Pelvic fracture Open or depressed skull fracture Paralysis Exclusion Criteria: Hospitalization < 24 hours ( transport of the patient to an other trauma center) Patients transported from an other hospital (first hours of medical support done elsewhere)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe trauma patients<br>No interventions are done. It's a prospective and descriptive observational study where different markers are analyzed: Blood Lactate levels Blood Base Excess levels Blood B-type Natriuretic Peptide levels Blood Thromboelastometry (ROTEM) alterations Near-infrared spectroscopy alterations Sublingual videomicroscopy alterations All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission. | Other: Blood Lactate<br>* Analyzed at the 1rst, 8th and 24th hour from hospital admission<br>Other: Blood Base Excess<br>* Analyzed at the 1rst, 8th and 24th hour from hospital admission<br>Other: Blood B-type Natriuretic Peptide<br>* Analyzed at the 1rst, 8th and 24th hour from hospital admission<br>Other: Blood Thromboelastometry (ROTEM)<br>* Analyzed at the 1rst, 8th and 24th hour from hospital admission<br>Other: Near-infrared spectroscopy<br>* Analyzed at the 1rst, 8th and 24th hour from hospital admission<br>Other: Sublingual videomicroscopy<br>* Analyzed at the 1rst, 8th and 24th hour from hospital admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death of the patient | Through study completion, an average of 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple organ dysfunction (Multiple Organ Dysfunction Score) | Marshall's score (MODS Score) consist on the analysis of 6 systems through different descriptors, those descriptors include: a) the respiratory system (pO2/FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirrubine concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale); and f) the cardiovascular system (pressure adjusted heart rate). The cardiovascular system descriptor is calculated as the product of the heart rate and the ratio of central venous pressure to mean arterial pressure. All these descriptors will be measured during the first 24h from hospital admission. | Through study completion, an average of 1-2 years | 
| Blood cell transfusion | Need for blood cell transfusion for patients | Through study completion, an average of 1-2 years | 
| Activation of the Massive blood transfusion protocol | Need for massive transfusion protocol activation on patients with suspicion of active bleeding | At hospital admission | 
| Surgical intervention for bleeding control | Need for surgical control on patients with active bleeding | Through study completion, an average of 1-2 years | 
| Arteriographic embolization for bleeding control | Need for arteriographic embolization on patients with active bleeding | Through study completion, an average of 1-2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microcirculation, Videomicroscopy, Spectroscopy, Near-Infrared, B-Type Natriuretic Peptide, Thromboelastometry, Trauma, Resuscitation, Hypovolemic shock