PDF(Pubmed)
Abstract：
Non-resuscitation fluids constitute the majority of fluid administered for septic shock patients in the intensive care unit (ICU). This multicentre, randomized, feasibility trial was conducted to test the hypothesis that a restrictive protocol targeting non-resuscitation fluids reduces the overall volume administered compared with usual care.
Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion.
Median (IQR) total volume of fluid in the first three days, was 6008 ml (interquartile range [IQR] 3960-8123) in the restrictive fluid group (n = 44), and 9765 ml (IQR 6804-12,401) in the control group (n = 48); corresponding to a Hodges-Lehmann median difference of 3560 ml [95% confidence interval 1614-5302]; p < 0.001). Outcome data on all-cause mortality, days alive and free of mechanical ventilation and acute kidney injury or ischemic events in the ICU within 90 days of inclusion were recorded in 98/98 (100%), 95/98 (98%) and 95/98 (98%) of participants respectively. Cognition and health-related quality of life at six months were recorded in 39/52 (75%) and 41/52 (79%) of surviving participants, respectively. Ninety out of 134 patients (67%) of eligible patients were randomized, and 15/98 (15%) of the participants experienced at least one protocol violation.
Protocolized reduction of non-resuscitation fluids in patients with septic shock resulted in a large decrease in fluid administration compared with usual care. A trial using this design to test if reducing non-resuscitation fluids improves outcomes is feasible.
Clinicaltrials.gov, NCT05249088, 18 February 2022. https://clinicaltrials.gov/ct2/show/NCT05249088.
Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion.
Median (IQR) total volume of fluid in the first three days, was 6008 ml (interquartile range [IQR] 3960-8123) in the restrictive fluid group (n = 44), and 9765 ml (IQR 6804-12,401) in the control group (n = 48); corresponding to a Hodges-Lehmann median difference of 3560 ml [95% confidence interval 1614-5302]; p < 0.001). Outcome data on all-cause mortality, days alive and free of mechanical ventilation and acute kidney injury or ischemic events in the ICU within 90 days of inclusion were recorded in 98/98 (100%), 95/98 (98%) and 95/98 (98%) of participants respectively. Cognition and health-related quality of life at six months were recorded in 39/52 (75%) and 41/52 (79%) of surviving participants, respectively. Ninety out of 134 patients (67%) of eligible patients were randomized, and 15/98 (15%) of the participants experienced at least one protocol violation.
Protocolized reduction of non-resuscitation fluids in patients with septic shock resulted in a large decrease in fluid administration compared with usual care. A trial using this design to test if reducing non-resuscitation fluids improves outcomes is feasible.
Clinicaltrials.gov, NCT05249088, 18 February 2022. https://clinicaltrials.gov/ct2/show/NCT05249088.
摘要：
目的：非复苏液体占重症监护病房（ICU）感染性休克患者的大部分液体。这个多中心，随机化，我们进行了可行性试验,以检验以下假设:与常规治疗相比,针对非复苏液的限制性方案减少了总给药体积.
方法：在6个瑞典ICU中，感染性休克的成人在入住ICU后的12小时内被随机分配，接受不复苏液体的减少或常规护理。主要结果是纳入后三天内给药的总液体量。
结果：前三天液体总体积的中位数（IQR），限制性流体组（n=44）为6008ml（四分位距[IQR]3960-8123），对照组（n=48）为9765ml（IQR6804-12,401）；对应于Hodges-Lehmann中位数差异为3560ml[95％置信区间1614-5302]；p<0.001）。关于全因死亡率的结果数据，在98/98（100%）中记录了ICU中90天内存活和无机械通气的天数以及急性肾损伤或缺血事件，参与者分别为95/98（98％）和95/98（98％）。在39/52（75％）和41/52（79％）的存活参与者中记录了六个月的认知和与健康相关的生活质量，分别。134名符合条件的患者中有90名（67%）被随机分组，和15/98（15％）的参与者经历了至少一个协议违反。
结论：与常规护理相比，减少感染性休克患者的非复苏液体，导致液体给药大幅减少。使用这种设计来测试减少非复苏液体是否可以改善结果的试验是可行的。
背景：Clinicaltrials.gov，NCT05249088，2022年2月18日。https://clinicaltrials.gov/ct2/show/NCT05249088.
方法：在6个瑞典ICU中，感染性休克的成人在入住ICU后的12小时内被随机分配，接受不复苏液体的减少或常规护理。主要结果是纳入后三天内给药的总液体量。
结果：前三天液体总体积的中位数（IQR），限制性流体组（n=44）为6008ml（四分位距[IQR]3960-8123），对照组（n=48）为9765ml（IQR6804-12,401）；对应于Hodges-Lehmann中位数差异为3560ml[95％置信区间1614-5302]；p<0.001）。关于全因死亡率的结果数据，在98/98（100%）中记录了ICU中90天内存活和无机械通气的天数以及急性肾损伤或缺血事件，参与者分别为95/98（98％）和95/98（98％）。在39/52（75％）和41/52（79％）的存活参与者中记录了六个月的认知和与健康相关的生活质量，分别。134名符合条件的患者中有90名（67%）被随机分组，和15/98（15％）的参与者经历了至少一个协议违反。
结论：与常规护理相比，减少感染性休克患者的非复苏液体，导致液体给药大幅减少。使用这种设计来测试减少非复苏液体是否可以改善结果的试验是可行的。
背景：Clinicaltrials.gov，NCT05249088，2022年2月18日。https://clinicaltrials.gov/ct2/show/NCT05249088.
