- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02772653
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Barcelona
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Sabadell, Barcelona, España, 08208
- Corporacion Sanitaria Parc Tauli
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mortality
Periodo de tiempo: Through study completion, an average of 1-2 years
|
Death of the patient
|
Through study completion, an average of 1-2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
Periodo de tiempo: 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
|
Blood cell transfusion
Periodo de tiempo: Through study completion, an average of 1-2 years
|
Need for blood cell transfusion for patients
|
Through study completion, an average of 1-2 years
|
Activation of the Massive blood transfusion protocol
Periodo de tiempo: At hospital admission
|
Need for massive transfusion protocol activation on patients with suspicion of active bleeding
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At hospital admission
|
Surgical intervention for bleeding control
Periodo de tiempo: Through study completion, an average of 1-2 years
|
Need for surgical control on patients with active bleeding
|
Through study completion, an average of 1-2 years
|
Arteriographic embolization for bleeding control
Periodo de tiempo: Through study completion, an average of 1-2 years
|
Need for arteriographic embolization on patients with active bleeding
|
Through study completion, an average of 1-2 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hospital stay
Periodo de tiempo: Through study completion, an average of 1-2 years
|
Number of days that the patient remains in hospital
|
Through study completion, an average of 1-2 years
|
Intensive care unit stay
Periodo de tiempo: Through study completion, an average of 1-2 years
|
Number of days that the patient remains in the intensive care unit
|
Through study completion, an average of 1-2 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andrea Campos-Serra, MD, Corporacion Sanitaria Parc Tauli
- Director de estudio: Salvador Navarro-Soto, MD, PhD, Corporacion Sanitaria Parc Tauli
- Director de estudio: Sandra Montmany-Vioque, MD, PhD, Corporacion Sanitaria Parc Tauli
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSPT-CG-PPT1
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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