Trauma and Acute Critical Care Center, Tokyo Medical and Dental University Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
Department of Acute Critical Care Medicine, Tsuchiura Kyodo General Hospital, 4-1-1 Otsuno, Tsuchiura, Ibaraki, Japan.
Trials. 2022 Sep 24;23(1):799. doi: 10.1186/s13063-022-06732-9.
Hemodynamic stabilization is a core component in the resuscitation of septic shock. However, the optimal target blood pressure remains debatable. Previous randomized controlled trials suggested that uniformly adopting a target mean arterial pressure (MAP) higher than 65 mmHg for all adult septic shock patients would not be beneficial; however, it has also been proposed that higher target MAP may be beneficial for elderly patients, especially those with arteriosclerosis.
A multicenter, pragmatic single-blind randomized controlled trial will be conducted to compare target MAP of 80-85 mmHg (high-target) and 65-70 mmHg (control) in the resuscitation of septic shock patients admitted to 28 hospitals in Japan. Patients with septic shock aged ≥65 years are randomly assigned to the high-target or control groups. The target MAP shall be maintained for 72 h after randomization or until vasopressors are no longer needed to improve patients' condition. To minimize the adverse effects related to catecholamines, if norepinephrine dose of ≥ 0.1 μg/kg/min is needed to maintain the target MAP, vasopressin will be initiated. Other therapeutic approaches, including fluid administration, hydrocortisone use, and antibiotic choice, will be determined by the physician in charge based on the latest clinical guidelines. The primary outcome is all-cause mortality at 90 days after randomization.
The result of this trial will provide great insight on the resuscitation strategy for septic shock in the era of global aged society. Also, it will provide the better understanding on the importance of individualized treatment strategy in hemodynamic management in critically ill patients.
UMIN Clinical Trials Registry; UMIN000041775. Registered 13 September 2020.
血流动力学稳定是脓毒性休克复苏的核心组成部分。然而，最佳的目标血压仍然存在争议。先前的随机对照试验表明，对所有成年脓毒性休克患者统一采用高于 65mmHg 的目标平均动脉压（MAP）可能没有益处；然而，也有人提出较高的目标 MAP 可能对老年患者有益，尤其是那些有动脉硬化的患者。
一项多中心、实用、单盲随机对照试验将比较在日本 28 家医院收治的脓毒性休克患者复苏中，目标 MAP 为 80-85mmHg（高目标组）和 65-70mmHg（对照组）的效果。年龄≥65 岁的脓毒性休克患者随机分为高目标组或对照组。随机分组后 72 小时内将维持目标 MAP，或直至血管加压剂不再需要改善患者病情。为尽量减少与儿茶酚胺相关的不良反应，如果需要≥0.1μg/kg/min 的去甲肾上腺素剂量来维持目标 MAP，将开始使用血管加压素。其他治疗方法，包括液体管理、氢化可的松使用和抗生素选择，将由主管医生根据最新的临床指南决定。主要结局为随机分组后 90 天的全因死亡率。
该试验的结果将为老龄化社会全球时代脓毒性休克的复苏策略提供重要的见解。此外，它还将更好地了解在危重病患者的血流动力学管理中个体化治疗策略的重要性。
UMIN 临床试验注册；UMIN000041775。注册于 2020 年 9 月 13 日。
