用伊伐布雷定控制心率对脓毒症患者血液动力学的影响：一项前瞻性多中心随机对照试验的研究方案。

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2024-10-23 DOI:10.1186/s13063-024-08560-5

Jiezhao Zheng, Deliang Wen, Zelin Pan, Xiaohua Chen, Tianyu Kong, Qirui Wen, Hongxuan Zhou, Weiyan Chen, Zhenhui Zhang

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引用次数: 0

摘要

简介脓毒症是一种危及生命的综合征，尽管低血容量和低血压已得到纠正，但仍常伴有心动过速。最近的相关研究表明，脓毒症患者持续心动过速与高死亡率有关，适当控制心率（HR）可改善预后。伊伐布雷定通过抑制If离子电流直接降低心率，而不产生负性肌力作用，这与传统的心率控制药物（β-受体阻滞剂）不同：这是一项前瞻性、多中心、随机、开放标签研究，旨在探讨伊伐布雷定控制心率对脓毒症患者血液动力学的影响。我们的研究将招募 172 名脓毒症患者，这些患者符合第三次国际脓毒症和脓毒性休克共识定义标准，尽管血液动力学已优化，但窦性心率仍在 95 bpm 或以上。患者将被随机分配到标准治疗组（GS）或伊伐布雷定组（GI，脓毒症标准治疗加肠内伊伐布雷定）。GI组患者将接受伊伐布雷定治疗，以维持心率在70-94 bpm之间。主要结果是在随机分组后的 96 小时内，GI 组与 GS 组患者的心率降至 95 bpm 以下的差异以及伊伐布雷定对血液动力学的影响。次要结果包括器官功能测量、SOFA评分差异、不良事件发生率、器官支持需求、ICU住院时间和28天总死亡率：有关伊伐布雷定控制脓毒症患者心率的研究十分有限。我们的研究旨在评估直接抑制窦房结是否能改善脓毒症患者的血流动力学及其对器官功能和预后的影响，从而为临床安全使用提供证据：试验注册：ClinicalTrials.gov NCT05882708。注册日期：2023 年 5 月 11 日，https://clinicaltrials.gov/ct2/show/NCT05882708 。

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Effect of heart rate control with ivabradine on hemodynamic in patients with sepsis: study protocol for a prospective, multicenter, randomized controlled trial.

Introduction: Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of hypovolemia and hypotension have been corrected. Recently, relevant studies have shown that sustained tachycardia in sepsis was related to high mortality, and appropriate control of heart rate (HR) could improve prognosis. Ivabradine reduces HR directly without a negative inotropic effect through inhibition of the I_f ionic current, which is different from the traditional rate control drug (beta-blockers).

Methods and analysis: This is a prospective, multicenter, randomized, open label study designed to investigate the effect of heart rate control with ivabradine on hemodynamic in patients with sepsis. Our study will enroll 172 patients with sepsis as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria with sinus rate of 95 bpm or higher despite a hemodynamic optimization. Patients will be randomly assigned to standard treatment group (GS) or ivabradine group (GI, standard treatment for sepsis plus enteral ivabradine). Patients in GI will receive ivabradine to maintain HR between 70 and 94 bpm. The primary outcome is the difference of a reduction in HR below 95 bpm and the effect of ivabradine on hemodynamics between GI and GS group within the first 96 h after randomization. The secondary outcomes include organ function measures, the difference in SOFA score, incidence of adverse events, need for organ support, length of ICU stay, and 28-day overall mortality.

Discussion: There are limited studies on ivabradine to control heart rate in patients with sepsis. Our study aims to evaluate whether direct sinus node inhibition can improve hemodynamics, as well as its impact on organ function and prognosis in patients with sepsis, so as to provide evidence for the safe usage in clinical practice.

Trial registration: ClinicalTrials.gov NCT05882708. Registered on May 11, 2023, https://clinicaltrials.gov/ct2/show/NCT05882708 .

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.