米多君用于重症监护病房中早期停用血管升压药支持治疗（LIBERATE）：一项可行性研究。
Midodrine for the early liberation from vasopressor support in the ICU (LIBERATE): a feasibility study.
作者信息
Kilcommons Sebastian J, Hammal Fadi, Opgenorth Dawn L, Fiest Kirsten M, Karvellas Constantine J, Lau Vincent I, MacIntyre Erika, Senaratne Janek, Slemko Jocelyn, Sligl Wendy, Zampieri Fernando, Duquette D 'Arcy, Guan Lily T, Baig Nadia, Bagshaw Sean M, Rewa Oleksa G
机构信息
University of Alberta, Edmonton, Canada.
Department of Critical Care Medicine, University of Alberta, Edmonton, Canada.
出版信息
Pilot Feasibility Stud. 2024 Dec 4;10(1):147. doi: 10.1186/s40814-024-01577-2.
BACKGROUND
Intravenous (IV) vasopressors are the mainstay of physiological support for hemodynamically unstable patients. However, the role of oral vasopressors remains unclear. The objective of our study was to evaluate the feasibility of evaluating midodrine for critically ill patients with IV vasopressor-dependent shock.
METHODS
We conducted a single-center, concealed-allocation, parallel-group, blinded feasibility randomized controlled trial (RCT) evaluating the effect of oral midodrine versus placebo on IV vasopressor-dependent shock in the intensive care unit (ICU). The study was performed in a medical-surgical ICU at the University of Alberta Hospital from April 2021 to July 2022. We included patients aged 18 years or older admitted to the ICU with ongoing vasopressor support with decreasing vasopressor dose(s). Patients were randomly assigned 1:1 to midodrine or a placebo for the duration of their IV vasopressor therapy. The primary outcome was study feasibility and secondary outcomes included patient-centered outcomes. Feasibility was assessed through rate of recruitment, adherence to study protocol, and patient safety.
RESULTS
Twenty patients were enrolled in the study and underwent randomization (n = 11 midodrine, n = 9 control). Recruitment was recorded at 1.2 participants per month, protocol adherence was 90%, and allocation remained concealed. No adverse events were reported in either group. Sepsis was the most common cause of shock in both groups. The midodrine group had a shorter length of ICU stay of 9.6 (SD 8.7) vs 10.4 (SD 14.5) days. Hospital mortality was lower for the midodrine group (n = 2, 18.2% vs n = 4, 37.5%). Vasopressor re-initiation after 24 h was more frequent in the midodrine group (n = 4, 36.4% vs n = 2, 25%). There were no readmissions to the ICU following discharge in either group.
CONCLUSIONS
The evaluation of midodrine for patients in the ICU is feasible and safe. This trial will inform future large-scale RCTs regarding the utility of midodrine in critically ill patients with IV vasopressor-dependent shock.
TRIAL REGISTRATION
This pilot RCT was registered at clinicaltrials.gov (NCT04489589). Registered July 27, 2020. https://clinicaltrials.gov/study/NCT04489589.
背景
静脉血管升压药是血流动力学不稳定患者生理支持的主要手段。然而，口服血管升压药的作用仍不明确。我们研究的目的是评估去氧肾上腺素对依赖静脉血管升压药的重症患者的可行性。
方法
我们进行了一项单中心、隐蔽分配、平行组、双盲可行性随机对照试验（RCT），评估口服去氧肾上腺素与安慰剂对重症监护病房（ICU）中依赖静脉血管升压药的休克患者的影响。该研究于2021年4月至2022年7月在阿尔伯塔大学医院的内科-外科ICU进行。我们纳入了18岁及以上入住ICU且正在接受血管升压药支持且血管升压药剂量逐渐减少的患者。在静脉血管升压药治疗期间，患者被随机1:1分配至去氧肾上腺素组或安慰剂组。主要结局是研究的可行性，次要结局包括以患者为中心的结局。通过招募率、对研究方案的依从性和患者安全性来评估可行性。
结果
20名患者纳入研究并进行了随机分组（去氧肾上腺素组n = 11，对照组n = 9）。每月招募1.2名参与者，方案依从性为90%，分配保持隐蔽。两组均未报告不良事件。脓毒症是两组中休克最常见的原因。去氧肾上腺素组的ICU住院时间较短，分别为9.6（标准差8.7）天和10.4（标准差14.5）天。去氧肾上腺素组的医院死亡率较低（n = 2，18.2%对n = 4，37.5%）。24小时后去氧肾上腺素组血管升压药重新使用更频繁（n = 4，36.4%对n = 2，25%）。两组出院后均未再次入住ICU。
结论
对ICU患者使用去氧肾上腺素进行评估是可行且安全的。该试验将为未来关于去氧肾上腺素在依赖静脉血管升压药的重症患者中的效用的大规模RCT提供信息。
试验注册
该初步RCT在clinicaltrials.gov（NCT04489589）注册。于2020年7月27日注册。https://clinicaltrials.gov/study/NCT04489589 。
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