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| Name | Class |
|---|---|
| Corporacion Parc Tauli | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe trauma patients | No interventions are done. It's a prospective and descriptive observational study where different markers are analyzed:
All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Lactate | Other | Analyzed at the 1rst, 8th and 24th hour from hospital admission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death of the patient | Through study completion, an average of 1-2 years |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | Number of days that the patient remains in hospital | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Campos-Serra, MD | Corporacion Sanitaria Parc Tauli | Principal Investigator |
| Salvador Navarro-Soto, MD, PhD | Corporacion Sanitaria Parc Tauli | Study Director |
| Sandra Montmany-Vioque, MD, PhD | Corporacion Sanitaria Parc Tauli | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporacion Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36053289 | Derived | Campos-Serra A, Mesquida J, Montmany-Vioque S, Rebasa-Cladera P, Barquero-Lopez M, Cidoncha-Secilla A, Llorach-Perucho N, Morales-Codina M, Puyana JC, Navarro-Soto S. Alterations in tissue oxygen saturation measured by near-infrared spectroscopy in trauma patients after initial resuscitation are associated with occult shock. Eur J Trauma Emerg Surg. 2023 Feb;49(1):307-315. doi: 10.1007/s00068-022-02068-w. Epub 2022 Sep 2. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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Blood samples for Natriuretic Peptide analysis. Retained just for one month, until samples are analyzed at an external laboratory.
| Blood Base Excess | Other | Analyzed at the 1rst, 8th and 24th hour from hospital admission |
|
| Blood B-type Natriuretic Peptide | Other | Analyzed at the 1rst, 8th and 24th hour from hospital admission |
|
| Blood Thromboelastometry (ROTEM) | Other | Analyzed at the 1rst, 8th and 24th hour from hospital admission |
|
| Near-infrared spectroscopy | Other | Analyzed at the 1rst, 8th and 24th hour from hospital admission |
|
| Sublingual videomicroscopy | Other | Analyzed at the 1rst, 8th and 24th hour 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 |
| Through study completion, an average of 1-2 years |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |