Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)

超声心动图治疗机制研究 (CLOVERS-STEM)

• 批准号: 10434725
• 负责人: Samuel Morris Brown
• 金额: $ 16.31万
• 依托单位: IHC HEALTH SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-10 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10434725
• 关键词: Affect; Ancillary Study; Area; Belief; Cardiac; Cardiomyopathies; Cardiotoxicity; Cardiovascular system; Catecholamines; Cessation of life; Clinical; Clinical Trials; Critical Care; Data; Echocardiography; Edema; Enrollment; Equilibrium; Evolution; Exhibits; Exposure to; Functional disorder; Funding; Future; Goals; Heart; Heterogeneity; Hour; Hypotension; IV Fluid; Immune response; Impairment; Infection; Inflammatory; Infusion procedures; Interdisciplinary Study; Intervention; Laboratories; Learning; Left; Left Ventricular Dysfunction; Left Ventricular Function; Liquid substance; Measures; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Nature; Organ; Outcome; Oxygen; Parents; Patients; Persons; Predisposition; Randomized; Randomized Controlled Trials; Research; Resolution; Resuscitation; Right Ventricular Dysfunction; Right ventricular structure; Risk; Safety; Seasons; Sepsis; Structure; Study Subject; Subgroup; Surrogate Endpoint; Techniques; Therapeutic; Tissues; Toxic effect; United States National Institutes of Health; Vasoconstrictor Agents; Ventricular; Work; base; biological adaptation to stress; clinical efficacy; cohort; crystalloid; disability; extracellular; heart function; human data; improved; innovation; intervention effect; mortality; myocardial injury; personalized management; pre-clinical; prospective; septic; septic patients; treatment effect; treatment strategy; ultrasound

Project Summary/Abstract Sepsis results when the host response to infection—comprising both immune and stress responses—leads to organ dysfunction, centrally cardiovascular dysfunction. The resulting sepsis-associated hypotension is lethal; how best to treat it is currently unknown. The two main treatments—intravenous fluid and catecholamine vasopressor infusions—both have toxicities, including direct effects on the heart, thus contributing to what is often termed septic cardiomyopathy. A large NIH/NHLBI-funded clinical trial, Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS), randomizes patients to competing strategies for treating sepsis-associated hypotension: liberal fluids (≥5L fluids before vasopressors) or early vasopressors (immediate vasopressors without additional fluids). CLOVERS represents an ideal laboratory for understanding the effects of management strategies on the evolution of septic cardiomyopathy, the relative contributions of right ventricular (RV) and left ventricular (LV) impairment to outcomes from septic cardiomyopathy, and the implications of baseline echocardiographic findings for the effect of treatments in certain groups of people. The Study of Treatment’s Echocardiographic Mechanisms (CLOVERS-STEM) is a prospective observational ancillary study within CLOVERS. Study subjects (N=210) will undergo speckle-tracked echocardiograms at enrollment and 24 hours later. Three integrated aims employ robust echocardiographic measures to assess the evolution of septic cardiomyopathy and differential susceptibility to treatment. Aim 1 assesses whether the early vasopressor treatment leads to LV impairment at 24 hours, as measured by global longitudinal strain. Aim 2 assesses whether the early vasopressor treatment leads to RV impairment, as measured by the ratio of RV to LV end-diastolic areas and RV free wall longitudinal strain. These two aims will also explore the contributions of LV and RV impairment to clinical endpoints. Aim 3 uses a validated continuous surrogate outcome—the change in multiple organ dysfunction on day 3—to explore possible heterogeneity of treatment effect based on the baseline echocardiographic results. This project innovates in multiple respects to dramatically advance our understanding of a major cause of global morbidity and mortality.

项目摘要/摘要 当宿主对感染的反应（会产生免疫反应和压力反应）时，会导致败血症 器官功能障碍，中央心血管功能障碍。由此产生的败血症相关性低血压致死。 当前如何最好地治疗它是未知的。两种主要治疗方法 - 液体和儿茶酚胺 加压剂输注 - 具有毒性，包括对心脏的直接影响，从而有助于什么 通常称为败血性心肌病。 大型NIH/NHLBI资助的临床试验，晶体自由主义者或加速器早期复苏 （三叶草），将患者随机竞争治疗败血症相关性低血压的策略：自由主义 液体（加压剂前≥5L液体）或早期加压剂（立即加速器，没有其他 流体）。三叶草是理解管理策略对的理想实验室 化脓性心肌病的演变，右心（RV）和左心室的相对贡献 （LV）败血性心肌病的结果以及基线超声心动图的影响 对某些人群治疗的影响的结果。治疗的超声心动图研究 机理（三叶草 - 茎）是三叶草内的前瞻性观察辅助研究。学习 受试者（n = 210）将在注册时和24小时后进行斑点跟踪的超声心动图。三 综合目的是员工强大的超声心动图测量，以评估化粪池心肌病的演变 和对治疗的差异敏感性。 AIM 1评估早期的加压剂治疗是否导致24小时的LV损伤，如 全球纵向应变。 AIM 2评估早期的加压剂治疗是否导致RV损伤，为 通过RV与LV端舒张区域的比率和RV游离壁纵向应变的比率。这两个目标将 还探索LV和RV损伤对临床终点的贡献。 AIM 3使用经过验证的 连续的替代结果 - 第3天多个器官功能障碍的变化 - 探索可能 基于基线超声心动图结果的治疗效果的异质性。该项目创新 多个方面要极大地提高我们对全球发病率和死亡率的主要原因的理解。

项目成果

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• DOI: 10.1016/j.chest.2017.02.029
• 发表时间: 2017
• 期刊: Chest
• 影响因子: 9.6
• 作者: Rush,Barret;Hertz,Paul;Bond,Alexandra;McDermid,RobertC;Celi,LeoAnthony
• 通讯作者: Celi,LeoAnthony

Unanticipated critical findings on echocardiography in septic patients.

脓毒症患者超声心动图意外的重要发现。

• DOI: 10.1186/s13089-020-00162-x
• 发表时间: 2020
• 期刊: The ultrasound journal
• 作者: Beesley,SarahJ;Egan,Ezekiel;Lanspa,MichaelJ;Wilson,EmilyL;Hirshberg,ElliotteL;Grissom,ColinK;Burk,Rebecca;Brown,SamuelM
• 通讯作者: Brown,SamuelM

What We Might Find If We Only Looked.

• DOI: 10.1016/j.chest.2021.01.013
• 发表时间: 2021-05
• 期刊: Chest
• 影响因子: 9.6
• 作者: Lanspa MJ;Brown SM
• 通讯作者: Brown SM

Identification of very low-risk acute chest pain patients without troponin testing.

• DOI: 10.1136/emermed-2020-209698
• 发表时间: 2020-11
• 期刊: Emergency medicine journal : EMJ
• 作者: Smith LM;Ashburn NP;Snavely AC;Stopyra JP;Lenoir KM;Wells BJ;Hiestand BC;Herrington DM;Miller CD;Mahler SA
• 通讯作者: Mahler SA