An observational study in Trauma and Hypovolemic Shock, sponsored by Andrea Campos-Serra. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Andrea Campos-Serra · Observational
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.
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's enrollment of 66 is below the median of 135 across 1,603 observational studies indexed under Wounds and Injuries.
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Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli
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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 · Other: Blood Base Excess · Other: Blood B-type Natriuretic Peptide · Other: Blood Thromboelastometry (ROTEM) · Other: Near-infrared spectroscopy · Other: Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Mortality
Death of the patient
Time frame: Through study completion, an average of 1-2 years
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.
Time frame: Through study completion, an average of 1-2 years
Blood cell transfusion
Need for blood cell transfusion for patients
Time frame: 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
Time frame: At hospital admission
Surgical intervention for bleeding control
Need for surgical control on patients with active bleeding
Time frame: Through study completion, an average of 1-2 years
Arteriographic embolization for bleeding control
Need for arteriographic embolization on patients with active bleeding
Time frame: Through study completion, an average of 1-2 years
Hospital stay
Number of days that the patient remains in hospital
Time frame: Through study completion, an average of 1-2 years
Intensive care unit stay
Number of days that the patient remains in the intensive care unit
Time frame: Through study completion, an average of 1-2 years
The record gives a start of May 2016, a primary completion of Mar 2019 and a completion of Mar 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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