Evaluation of Resuscitation Markers in Trauma Patients
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Barcelona
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Sabadell, Barcelona, Espanha, 08208
- Corporación Sanitaria Parc Taulí
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mortality
Prazo: Through study completion, an average of 1-2 years
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Death of the patient
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Through study completion, an average of 1-2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
Prazo: 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.
|
Through study completion, an average of 1-2 years
|
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Blood cell transfusion
Prazo: Through study completion, an average of 1-2 years
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Need for blood cell transfusion for patients
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Through study completion, an average of 1-2 years
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Activation of the Massive blood transfusion protocol
Prazo: At hospital admission
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Need for massive transfusion protocol activation on patients with suspicion of active bleeding
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At hospital admission
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Surgical intervention for bleeding control
Prazo: Through study completion, an average of 1-2 years
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Need for surgical control on patients with active bleeding
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Through study completion, an average of 1-2 years
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Arteriographic embolization for bleeding control
Prazo: Through study completion, an average of 1-2 years
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Need for arteriographic embolization on patients with active bleeding
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Through study completion, an average of 1-2 years
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hospital stay
Prazo: Through study completion, an average of 1-2 years
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Number of days that the patient remains in hospital
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Through study completion, an average of 1-2 years
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Intensive care unit stay
Prazo: Through study completion, an average of 1-2 years
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Number of days that the patient remains in the intensive care unit
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Through study completion, an average of 1-2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andrea Campos-Serra, MD, Corporación Sanitaria Parc Taulí
- Diretor de estudo: Salvador Navarro-Soto, MD, PhD, Corporación Sanitaria Parc Taulí
- Diretor de estudo: Sandra Montmany-Vioque, MD, PhD, Corporación Sanitaria Parc Taulí
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CSPT-CG-PPT1
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