背景:创伤性脑损伤(TBI)是全球健康问题,具有重大的经济影响。最佳液体疗法旨在恢复血管内容量,维持脑灌注压和血流量,从而防止继发性脑损伤。虽然通常使用0.9%盐水(NS),对酸碱和电解质失衡以及急性肾损伤(AKI)发展的担忧导致考虑将平衡液体作为替代方案。
目的:本研究的目的是比较中至重度TBI患者接受STROFYDIN(SF)和NS治疗的结果。
方法:2017年2月至2019年11月在马来亚大学医学中心进行了一项针对18至65岁TBI患者的双盲随机对照试验。
■患者被随机分配接受NS或SF。以连续输注或推注的方式施用研究液72小时。参与者,调查员,工作人员对液体类型视而不见。
方法:主要结局是住院死亡率。计算95%置信区间(CI)的相对危险度(RR)。
结果:共70例患者纳入分析,NS组38,SF组32。NS组的住院死亡率为3(7.9%)。4(12.5%)在SF组中,RR=1.29(95%CI,0.64至2.59;p=0.695)。没有患者发生AKI并需要肾脏替代治疗。SF组第3天的ICP明显高于NS组的12.77±3.63(18.60±9.26),(95%CI,-11.46至0.20;p=0.037)。3天生化指标和脑灌注压差异无统计学意义,无呼吸机日,ICU住院时间,或6个月时的格拉斯哥结局扩展量表(GOS-E)评分。
结论:在中度至重度TBI患者中,使用SF与降低住院死亡率无关,AKI的发展,与NS相比,或改善了6个月的GOS-E。
Traumatic brain injury (TBI) is a global health concern with significant economic impact. Optimal fluid therapy aims to restore intravascular volume, maintain cerebral perfusion pressure and blood flow, thus preventing secondary brain injury. While 0.9% saline (NS) is commonly used, concerns about acid-base and electrolyte imbalance and development of acute kidney injury (AKI) lead to consideration of balanced fluids as an alternative.
This study aimed to compare the outcomes of patients with moderate to severe TBI treated with Sterofundin (SF) versus NS.
A double-blinded randomised controlled trial of patients aged 18 to 65 years with TBI was conducted at the University Malaya Medical Centre from February 2017 to November 2019.
Patients were randomly assigned to receive either NS or SF. The study fluids were administered for 72 h as continuous infusions or boluses. Participants, investigators, and staff were blinded to the fluid type.
The primary outcome was in-hospital mortality. Relative risk (RR) with 95% confidence interval (CI) was calculated.
A total of 70 patients were included in the analysis, with 38 in the NS group and 32 in the SF group. The in-hospital mortality rate were 3 (7.9%) in the NS group vs. 4 (12.5%) in the SF group, RR = 1.29 (95% CI, 0.64 to 2.59; p = 0.695). No patients developed AKI and required renal replacement therapy. ICP on day 3 was significantly higher in the SF group (18.60 ± 9.26) compared to 12.77 ± 3.63 in the NS group, (95% CI, -11.46 to 0.20; p = 0.037). There were no significant differences in 3-day biochemical parameters and cerebral perfusion pressure, ventilator-free days, length of ICU stay, or Glasgow Outcome Scale-Extended (GOS-E) score at 6 months.
In patients with moderate to severe TBI, the use of SF was not associated with reduced in-hospital mortality, development of AKI, or improved 6-month GOS-E when compared to NS.