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.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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Barcelona
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Sabadell、Barcelona、西班牙、08208
- Corporacion Sanitaria Parc Tauli
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mortality
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
大体时间:Through study completion, an average of 1-2 years
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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.
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Through study completion, an average of 1-2 years
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Blood cell transfusion
大体时间: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
大体时间: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
大体时间: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
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Hospital stay
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Andrea Campos-Serra, MD、Corporacion Sanitaria Parc Tauli
- 研究主任:Salvador Navarro-Soto, MD, PhD、Corporacion Sanitaria Parc Tauli
- 研究主任:Sandra Montmany-Vioque, MD, PhD、Corporacion Sanitaria Parc Tauli
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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创伤的临床试验
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Riverside University Health System Medical Center未知
Blood Lactate的临床试验
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Norwegian University of Science and TechnologySt. Olavs Hospital完全的