Evaluation of Resuscitation Markers in Trauma Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Severe trauma patients 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
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Other: Blood Base Excess
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Other: Blood B-type Natriuretic Peptide
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Other: Blood Thromboelastometry (ROTEM)
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Other: Near-infrared spectroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Other: Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
|
Outcome Measures
Primary Outcome Measures
- Mortality [Through study completion, an average of 1-2 years]
Death of the patient
Secondary Outcome Measures
- Multiple organ dysfunction (Multiple Organ Dysfunction Score) [Through study completion, an average of 1-2 years]
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.
- Blood cell transfusion [Through study completion, an average of 1-2 years]
Need for blood cell transfusion for patients
- Activation of the Massive blood transfusion protocol [At hospital admission]
Need for massive transfusion protocol activation on patients with suspicion of active bleeding
- Surgical intervention for bleeding control [Through study completion, an average of 1-2 years]
Need for surgical control on patients with active bleeding
- Arteriographic embolization for bleeding control [Through study completion, an average of 1-2 years]
Need for arteriographic embolization on patients with active bleeding
Other Outcome Measures
- Hospital stay [Through study completion, an average of 1-2 years]
Number of days that the patient remains in hospital
- Intensive care unit stay [Through study completion, an average of 1-2 years]
Number of days that the patient remains in the intensive care unit
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pre-hospital Priority 0 protocol activation:
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Glasgow coma scale < 14
-
Systolic blood pressure < 90 mmHg
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Respiratory rate < 10 or > 29 breaths per minute
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Absent peripheral pulses
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Pre-hospital Priority 1 protocol activation:
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All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
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Flail chest
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Two or more proximal long-bone fractures
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Crushed, degloved or mangled extremity
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Amputation proximal to wrist and ankle
-
Pelvic fracture
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Open or depressed skull fracture
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Corporacion Sanitaria Parc Tauli | Sabadell | Barcelona | Spain | 08208 |
Sponsors and Collaborators
- Andrea Campos-Serra
- Corporacion Parc Tauli
Investigators
- Principal Investigator: Andrea Campos-Serra, MD, Corporacion Sanitaria Parc Tauli
- Study Director: Salvador Navarro-Soto, MD, PhD, Corporacion Sanitaria Parc Tauli
- Study Director: Sandra Montmany-Vioque, MD, PhD, Corporacion Sanitaria Parc Tauli
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPT-CG-PPT1