针对严重脓毒症和脓毒性休克成人患者的骨骼肌组织氧合（StO）：一项随机对照试验（OTO-StS研究）
Targeting skeletal muscle tissue oxygenation (StO) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study).
作者信息
Nardi Olivier, Zavala Elizabeth, Martin Claude, Nanas Serafim, Scheeren Thomas, Polito Andrea, Borrat Xavi, Annane Djillali
机构信息
Intensive Care Unit, Raymond Poincaré Hospital, Assistance Publique Hôpitaux de Paris and Laboratory of Inflammation and Infection UMR 1173, University of Versailles SQY and INSERM, Garches, France.
Department of Anesthesiology and Intensive Care Medicine Hospital Clinic, University of Barcelona, Barcelona, Spain.
出版信息
BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.
OBJECTIVE
Evaluation of the ratio of oxyhaemoglobin to total haemoglobin in skeletal muscle (StO) using near-infrared spectroscopy may aid in the monitoring of patients with sepsis. This study assessed the benefits and risks of targeting StO in adults with severe sepsis or septic shock.
DESIGN
A European randomised controlled trial was performed on two parallel groups.
SETTING
Five intensive care units (ICU) in France, Greece, Spain and Germany were used for the study.
PARTICIPANTS
A total of 103 adults with severe sepsis or septic shock on ICU admission were randomised (54 subjects in the experimental arm and 49 subjects in the control arm).
INTERVENTIONS
Haemodynamic management using an algorithm that was adapted from the 2004 Surviving Sepsis Campaign guidelines with (experimental arm) or without (control arm) targeting an StO value greater than 80% at a minimum of two different sites.
OUTCOMES
The primary outcome was a composite: 7-day all-cause mortality or worsening of organ function, defined as a positive difference in Sepsis-related Organ Failure Assessment (SOFA) score between day 7 and randomisation (ie, delta SOFA >0). Secondary endpoints: 30-day mortality, duration of mechanical ventilation and vasopressor therapy up to 30 days from randomisation.
RESULTS
The study ended prematurely due to lack of funding after enrolment of 103/190 patients. Eighteen patients (33.3%) in the experimental arm and 14 (28.6%, P=0.67) in the control arm died or exhibited delta SOFA >0 on day 7. The mean number of days on mechanical ventilation was 12.2±10.6 in the experimental group and 7.6±7.9 in the control group (P=0.03). Thirty-one (57%) patients in the experimental arm and 14 (29%) patients in the control arm received red cells by day 7 (P=0.01).
CONCLUSION
Despite the limitation related to premature termination, this study provides no data to support the routine implementation of resuscitation protocols incorporating StO >80% at two or more muscle sites as a target. StO-guided therapy may be associated with prolonged use of mechanical ventilation and an increased number of red blood cell transfusions.
TRIAL REGISTRATION NUMBER
NCT00167596; Results.
目的
使用近红外光谱法评估骨骼肌中氧合血红蛋白与总血红蛋白的比例（StO），可能有助于脓毒症患者的监测。本研究评估了在严重脓毒症或脓毒性休克成人患者中以StO为目标的益处和风险。
设计
在两个平行组上进行了一项欧洲随机对照试验。
设置
法国、希腊、西班牙和德国的五个重症监护病房（ICU）用于该研究。
参与者
共有103名入住ICU时患有严重脓毒症或脓毒性休克的成人被随机分组（试验组54名受试者，对照组49名受试者）。
干预措施
采用一种算法进行血流动力学管理，该算法改编自2004年《拯救脓毒症运动》指南，试验组在至少两个不同部位以StO值大于80%为目标，对照组则无此目标。
结果
主要结局是一个复合指标：7天全因死亡率或器官功能恶化，定义为第7天与随机分组时脓毒症相关器官功能衰竭评估（SOFA）评分的正向差异（即，SOFA差值>0）。次要终点：30天死亡率、机械通气时间以及从随机分组起至30天的血管活性药物治疗时间。
结果
在纳入103/190例患者后，由于资金短缺，研究提前结束。试验组18例患者（33.3%）和对照组14例患者（28.6%，P = 0.67）在第7天死亡或SOFA差值>0。试验组机械通气的平均天数为12.2±10.6天，对照组为7.6±7.9天（P = 0.03）。试验组31例（57%）患者和对照组14例（29%）患者在第7天接受了红细胞输注（P = 0.01）。
结论
尽管存在与提前终止相关的局限性，但本研究没有提供数据支持将在两个或更多肌肉部位将StO>80%纳入复苏方案作为常规实施目标。以StO为导向的治疗可能与机械通气时间延长和红细胞输注数量增加有关。
试验注册号
NCT00167596；结果
Zotero 插件