减少严重胰腺炎炎炎症的皮质类固醇 (CRISP) 协议和统计分析计划:一个前性的,多中心的,双盲的,随机的,安慰剂控制的临床试验
Jacob Vine1, Noa Berlin2, Ari Moskowitz3
1Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, 1 Deaconess Road, Rosenberg 2, Boston, MA 02215, USA.
Contemporary clinical trials
|March 2, 2024
概括
这项临床试验调查皮质类固醇是否可以减少严重急性胰腺炎的器官衰竭. 结果将指导未来对这种严重疾病的治疗.
科学领域:
- 关键护理医学 关键护理医学
- 胃肠病学 胃肠病学
- 临床试验中的临床试验.
背景情况:
- 严重的急性胰腺炎具有显著的发病率和死亡率.
- 目前的治疗依赖于支持性护理,缺乏器官衰竭的特定疗法.
- 皮质类固醇可以减轻全身炎症,可能改善结果.
研究的目的:
- 评估皮质类固醇在严重急性胰腺炎中减少器官损伤的疗效.
- 在一个随机对照试验中,将皮松治疗与安慰剂进行比较.
- 评估皮质类固醇对严重急性胰腺炎患者关键临床结果的影响.
主要方法:
- 多中心,双盲,随机,安慰剂对照试验 (CRISP试验).
- 患者接受了亲肠道皮 (100毫克每8小时3天) 或安慰剂.
- 主要终点:顺序性器官衰竭评估 (SOFA) 评分的72小时变化.
主要成果:
- 在入学时和24,48,72小时收集数据.
- 二次结局包括无呼吸器日和28天死亡率.
- 分析SOFA分数的变化,以确定治疗疗效.
结论:
- 这项研究旨在为治疗严重急性胰腺炎提供关键证据.
- 结果将为临床实践和未来的研究方向提供信息.
- 该试验已在clinicaltrials.gov (NCT05160506) 上注册.
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