Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore.
Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Ann Emerg Med. 2016 Mar;67(3):367-378.e3. doi: 10.1016/j.annemergmed.2015.09.010. Epub 2015 Oct 23.
The noninvasive cardiac output monitor and passive leg-raising maneuver has been shown to be reasonably accurate in predicting fluid responsiveness in critically ill patients. We examine whether using a noninvasive protocol would result in more rapid lactate clearance after 3 hours in patients with severe sepsis and septic shock in the emergency department.
In this open-label randomized controlled trial, 122 adult patients with sepsis and serum lactate concentration of greater than or equal to 3.0 mmol/L were randomized to receive usual care or intravenous fluid bolus administration guided by measurements of change of stroke volume index, using the noninvasive cardiac output monitor after passive leg-raising maneuver. The primary outcome was lactate clearance of more than 20% at 3 hours. Secondary outcomes included mortality, length of hospital and ICU stay, and total hospital cost. Analysis was intention to treat.
Similar proportions of patients in the randomized intervention group (70.5%; N=61) versus control group (73.8%; N=61) achieved the primary outcome, with a relative risk of 0.96 (95% confidence interval [CI] 0.77 to 1.19). Secondary outcomes were similar in both groups (P>.05 for all comparisons). Hospital mortality occurred in 6 patients (9.8%) each in the intervention and control groups on or before 28 days (relative risk=1.00; 95% CI 0.34 to 2.93). Among a subgroup of patients with underlying fluid overload states, those in the intervention group tended to receive clinically significantly more intravenous fluids at 3 hours (difference=975 mL; 95% CI -450 to 1,725 mL) and attained better lactate clearance (difference=19.7%; 95% CI -34.6% to 60.2%) compared with the control group, with shorter hospital lengths of stay (difference=-4.5 days; 95% CI -9.5 to 2.5 days).
Protocol-based fluid resuscitation of patients with severe sepsis and septic shock with the noninvasive cardiac output monitor and passive leg-raising maneuver did not result in better outcomes compared with usual care. Future studies to demonstrate the use of the noninvasive protocol-based care in patients with preexisting fluid overload states may be warranted.
无创心输出量监测和被动抬腿试验已被证明可在危重病患者中合理地准确预测液体反应性。我们研究了在急诊科患有严重脓毒症和感染性休克的患者中，使用非侵入性方案是否会导致乳酸清除率在 3 小时内更快。
在这项开放标签的随机对照试验中，122 名脓毒症血清乳酸浓度大于或等于 3.0mmol/L 的成年患者被随机分为常规治疗组或在被动抬腿试验后使用无创心输出量监测仪指导静脉输液。主要结局为 3 小时时乳酸清除率大于 20%。次要结局包括死亡率、住院和 ICU 住院时间以及总住院费用。分析采用意向治疗。
随机干预组（70.5%；N=61）和对照组（73.8%；N=61）的患者达到主要结局的比例相似，相对风险为 0.96（95%置信区间[CI]0.77 至 1.19）。两组的次要结局相似（所有比较 P>.05）。两组各有 6 名患者（9.8%）在 28 天内或之前发生院内死亡（相对风险=1.00；95%CI0.34 至 2.93）。在有潜在液体超负荷状态的患者亚组中，与对照组相比，干预组在 3 小时时接受了临床意义上更多的静脉输液（差异=975mL；95%CI-450 至 1725mL），乳酸清除率更好（差异=19.7%；95%CI-34.6%至 60.2%），住院时间更短（差异=-4.5 天；95%CI-9.5 至 2.5 天）。
与常规治疗相比，使用无创心输出量监测和被动抬腿试验对严重脓毒症和感染性休克患者进行基于方案的液体复苏并未带来更好的结局。未来可能需要研究在存在先前液体超负荷状态的患者中使用基于无创方案的护理。
