创伤患者预后中的炎症标志物
2025年6月4日 更新者：Arun Aneja
对创伤的炎症反应 - 早期细胞因子调节是否改善患者预后
尚不清楚炎性细胞因子的早期调节是否与改善患者预后、减少骨科患者群体的麻醉剂需求以及改善患者出院后的主观疼痛有关。 初步的动物和临床研究表明，创伤急性期血液细胞因子浓度升高与创伤后并发症的发生之间存在相关性。 在动物中早期使用非甾体类抗炎药 (NSAID) 可显着降低炎症特征、改善肺水肿并增强小动脉血管收缩以应对出血。 通过短期服用非甾体类抗炎药 (NSAID) 来改变创伤后生理反应的能力可能会改善患者的预后。 此外，鉴于目前美国阿片类药物流行的情况，急性创伤期间的替代性非阿片类药物疼痛管理有可能减少阿片类药物的消耗，并且是多模式镇痛策略的关键组成部分。
通过进行这项研究，研究人员希望了解如何为肯塔基州的所有患者提供最好的护理。 患者参与本研究将持续约 1 年。
研究概览
详细说明
意外创伤是美国第四大死因，并且与复杂的炎症反应有关。 这种反应与创伤后并发症有关，例如；多器官功能障碍综合征 (MODS)、细菌性肺炎、急性呼吸窘迫综合征 (ARDS)、全身炎症反应综合征 (SIRS) 和创伤后疼痛 (PTP)。 尚不清楚炎性细胞因子的早期调节是否与改善患者预后、减少麻醉药需求以及改善患者出院后的主观疼痛有关。
初步数据显示：(1) 创伤急性期血液细胞因子浓度升高与致命的创伤后并发症的发生相关，(2) 早期服用非甾体抗炎药 (NSAID) 导致在动物模型中降低血清 IL-6、前列腺素 E2 (PGE2) 水平，改善肺水肿，增强小动脉响应出血的血管收缩能力，以及 (3) 添加内部生理参数（炎性细胞因子）与单独的 NISS 相比，新的损伤严重程度评分（NISS - 外部解剖损伤的标志）显着提高了预测创伤患者住院时间的能力。 研究小组率先使用综合方法，将外部解剖损伤数据与内部生理反应相结合，以准确预测患者的临床结果。 因此，如果研究人员将同样的心态应用于治疗，研究人员可以通过解决这两个参数来改善创伤患者的护理，而不是像过去那样只关注外部伤害。 通过短期服用非甾体抗炎药来改变创伤后生理反应的能力可能会改善患者的预后。
在过去的十年中，临床医生仍然对骨折后 NSAID 给药在骨愈合方面的安全性感到困惑。 此外，鉴于目前美国阿片类药物流行的情况，急性创伤期间的替代性非阿片类药物疼痛管理有可能减少阿片类药物的消耗，并且是多模式镇痛策略的关键组成部分。
研究类型
介入性
注册 (实际的)
70
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kentucky
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Lexington、Kentucky、美国、40536
- University of Kentucky
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
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排除标准：
- 患者年龄 < 18 岁或 > 65 岁
- 评估前超过 24 小时受伤的患者
- 失血性休克或大出血的风险。
- 患有炎症性关节病或炎症性肠病等炎症性疾病的患者
- 获得性免疫缺陷综合症（艾滋病）患者
- 怀孕的患者
- 活动性胃肠道出血或溃疡患者
- 长期使用类固醇或免疫调节药物或有器官移植史的患者
- 既往患有慢性肾脏、肝脏或肺部疾病的患者
- 有心肌梗塞病史的患者
- 慢性心力衰竭患者
- 对 NSAID 过敏的患者
- 凝血缺陷患者（凝血因子缺乏症、血栓形成倾向或任何出血性疾病）
- 接受慢性阿片类药物治疗或阿片类药物使用障碍治疗的患者。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：没有NSAID的护理标准
根据标准的高级创伤生命支持（ATLS）和标准的ICU常规医疗服务，Polytrauma参与者还将获得护理标准。
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参与者将在住院的前5天接受每6小时的1毫升盐溶液IV
其他名称：
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实验性的：NSAID的护理标准
除了标准的高级创伤生命支持（ATLS）和标准ICU常规医疗服务的标准外，该小组的参与者还将获得Ketorolac。
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参与者将在住院的前5天每6小时以15 mg IV收到Ketorolac
其他名称：
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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 |
|---|---|---|
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住院时间
大体时间：最多 30 天
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住院时间将从电子健康记录中计算
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最多 30 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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死亡
大体时间：最多 30 天
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将记录前 30 天与初始外伤/外伤并发症相关的死亡发生率。
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最多 30 天
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吗啡毫克等效物
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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在整个医院住院期间，将记录吗啡毫克等效物（MME）。
这些将报告为每日总计。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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患者疼痛评分的变化
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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该患者报告的疼痛评分（视觉模拟疼痛评分）将在整个医院住院期间记录。
该分数由患者报告，从0表示没有疼痛到100，这意味着可以想象的最严重的疼痛。
这些将报告为每日平均。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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改变白介素1a
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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住院前5天的每日血液收集。
白介素1a将由三明治ELISA测量，数据将作为白介素1的基线水平的变化显示，从介绍到急诊室再到住院第5天。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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改变白介素1B
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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住院前5天的每日血液收集。
白介素1b将由三明治ELISA测量，数据将作为白介素1的基线水平的变化显示，从介绍到急诊室再到住院第5天。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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改变白介素6
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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住院前5天的每日血液收集。
白介素6将由三明治ELISA测量，数据将作为白介素6基线水平的变化显示，从介绍到急诊室再到住院第5天。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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变成白介素10
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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住院前5天的每日血液收集。
白介素10将由三明治ELISA测量，数据将作为白介素10的基线水平的变化显示，从介绍到急诊室再到住院的第5天。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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更改前列腺素E-2
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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在住院5天的过程中，血液将收集。
Prostaglandin E-2将由三明治ELISA测量，数据将作为Prostaglandin E-2的基线水平的变化，从介绍到急诊室再到住院第5天
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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创伤后并发症
大体时间：最多30天
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患者创伤后并发症的发生率包括但不限于肺部并发症发生（即细菌性肺炎，肺水肿，急性呼吸衰竭）和AKI的发生率，通常会在整个医院持续时间内记录，通常为30天。
数据将作为具有诊断后创伤后并发症的参与者的百分比提供。
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最多30天
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更改住院的主观疼痛报告
大体时间：医院第0天（注册），第1天，第3天，第3天，第4天，第5天
|
该患者报告的疼痛评分（视觉模拟疼痛评分）将在整个医院住院期间记录。
该分数由患者报告，从0表示没有疼痛到100，这意味着可以想象的最严重的疼痛。
这些将报告为每日平均。
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医院第0天（注册），第1天，第3天，第3天，第4天，第5天
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改变门诊的主观疼痛报告
大体时间：最多365天
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患者报告疼痛程度以及抑制其日常活动的程度将在门诊环境中记录。
该分数由患者报道（视觉模拟量表），范围从0表示疼痛到100，这意味着可想象的最严重的疼痛。
这将报告每次患者随访访问。
可能的访问是可能的，只有在随访的第一年才收集数据。
数据显示为受试者疼痛的变化从基线到365天。
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最多365天
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Arun Aneja, MD、University of Kentucky
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年2月28日
初级完成 (实际的)
2023年6月20日
研究完成 (实际的)
2023年6月20日
研究注册日期
首次提交
2018年9月12日
首先提交符合 QC 标准的
2018年9月13日
首次发布 (实际的)
2018年9月14日
研究记录更新
最后更新发布 (估计的)
2025年6月5日
上次提交的符合 QC 标准的更新
2025年6月4日
最后验证
2025年6月1日
更多信息
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