Dong Lipeng, Wu Xinhui, Zhao Congcong, Ge Shengmei, Liu Zhihong
Department of Critical Care Medicine, Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, Hebei, China. Corresponding author: Wu Xinhui, Email:
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2025 Mar;37(3):237-244. doi: 10.3760/cma.j.cn121430-20240711-00583.
To evaluate the risks and benefits of different resuscitation fluids in patients with early sepsis and septic shock by observing and comparing clinical indicators, clinical outcomes, and the concentration changes of glycocalyx biomarkers, and to determine how to appropriately select suitable resuscitation fluids for sepsis patients to aid fluid therapy.
A single center, prospective, randomized controlled trial was conducted. Patients with early sepsis and septic shock who have required fluid resuscitation after capacity status assessment admitted to the department of critical care medicine of Fourth Hospital of Hebei Medical University from April to October 2023 were enrolled. Patients were randomly assigned to either the experimental group (balanced crystalloid solution+albumin) or the control group (balanced crystalloid solution) by a random number table method. Clinical data of both groups of patients before and after resuscitation at 3, 8, and 24 hours were monitored, and blood samples were collected, enzyme-linked immunosorbent assay (ELISA) was used to measure the concentration of plasma glycocalyx biomarker syndecan-1. The 28-day and 90-day survival rates and complications were also assessed.
A total of 66 patients were enrolled, including 44 in the experimental group and 22 in the control group. The baseline data of two groups were balanced and comparable. There was no statistically significant difference in the plasma concentration of syndecan-1 between the experimental group and the control group before and after resuscitation, and both showed a trend of first increasing and then decreasing. However, the plasma syndecan-1 level in the control group at 8 hours and 24 hours after resuscitation were significantly higher than the baseline level before resuscitation [ng/L: 19.02 (14.41, 27.80), 18.95 (12.40, 22.50) vs. 14.67 (11.57, 21.14), both P < 0.05], while there was no statistically significant difference at any time point within the experimental group. The correlation analysis between plasma syndecan-1 level and lactic acid, albumin, and sequential organ failure assessment (SOFA) in all patients showed that a positive correlation between syndecan-1 level and SOFA score before resuscitation (r = 0.247, P = 0.046), and a negative correlation between syndecan-1 level and albumin level at 24 hours after resuscitation (r = -0.308, P = 0.012). There were no statistically significant differences in 28-day and 90-day mortality, length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation, blood purification time, number of organ injuries, and complications between the two groups. However, the baseline albumin level in the experimental group was significantly lower than that in the control group (g/L: 28.7±4.5 vs. 31.6±4.2, P < 0.05). Analysis of clinical treatment data showed that compared with the control group, the experimental group had lower absolute lactate level at 8 hours and 24 hours after resuscitation [mmol/L: 8 hours was 1.30 (1.00, 1.88) vs. 1.60 (1.30, 3.05), 24 hours was 1.15 (0.80, 1.78) vs. 1.55 (1.08, 2.05), both P < 0.05], and higher lactate clearance rate [8 hours was 45% (27%, 56%) vs. 20% (-4%, 46%), 24 hours was 55% (34%, 70%) vs. 34% (-14%, 59%), both P < 0.05]. However, there were no statistically significant differences in the amount of fluid resuscitation, use of vasoactive drugs, and oxygenation index between the two groups during the resuscitation process. Multivariate Logistic regression analysis showed that body mass index (BMI) was independently correlated with 90-day mortality [odds ratio (OR) = 1.991, 95% confidence interval (95%CI) was 1.023-3.387, P = 0.043].
There are no significant difference in plasma syndecan-1 level during fluid resuscitation of early sepsis and septic shock patients using balanced crystalloid fluid and balanced crystalloid fluid combined with albumin resuscitation, and there are no statistically significant differences in the impact on 28-day and 90-day prognosis, length of hospital stay, complications, and other aspects of the patients. However, compared to balanced crystalloid fluid, the combination of balanced crystalloid fluid and albumin for fluid resuscitation in sepsis patients has lower lactate level and better lactate clearance effect, but further validation is still needed through large-scale randomized controlled trials.
通过观察和比较临床指标、临床结局以及糖萼生物标志物的浓度变化,评估不同复苏液体对早期脓毒症和脓毒性休克患者的风险和益处,并确定如何为脓毒症患者适当选择合适的复苏液体以辅助液体治疗。
进行一项单中心、前瞻性、随机对照试验。纳入2023年4月至10月在河北医科大学第四医院重症医学科住院,经容量状态评估后需要液体复苏的早期脓毒症和脓毒性休克患者。采用随机数字表法将患者随机分为实验组(平衡晶体液+白蛋白)和对照组(平衡晶体液)。监测两组患者复苏前、复苏后3、8和24小时的临床资料,并采集血样,采用酶联免疫吸附测定(ELISA)法检测血浆糖萼生物标志物syndecan-1的浓度。同时评估28天和90天生存率及并发症。
共纳入66例患者,其中实验组44例,对照组22例。两组基线数据均衡可比。实验组和对照组复苏前后血浆syndecan-1浓度差异无统计学意义,且均呈先升高后降低趋势。但对照组复苏后8小时和24小时血浆syndecan-1水平显著高于复苏前基线水平[ng/L:19.02(14.41,27.80),18.95(12.40,22.50) vs. 14.67(11.57,21.14),均P<0.05],而实验组各时间点差异无统计学意义。所有患者血浆syndecan-1水平与乳酸、白蛋白及序贯器官衰竭评估(SOFA)的相关性分析显示,复苏前syndecan-1水平与SOFA评分呈正相关(r = 0.247,P = 0.046),复苏后24小时syndecan-1水平与白蛋白水平呈负相关(r = -0.308,P = 0.012)。两组28天和90天死亡率、住院时间、重症监护病房(ICU)住院时间、机械通气时间、血液净化时间、器官损伤数量及并发症差异均无统计学意义。然而,实验组基线白蛋白水平显著低于对照组(g/L:28.7±4.5 vs. 31.6±4.2,P<0.05)。临床治疗数据分析显示,与对照组相比,实验组复苏后8小时和24小时的绝对乳酸水平更低[mmol/L:8小时为1.30(1.00,1.88) vs. 1.60(1.30,3.05),24小时为1.15(0.80,1.78) vs. 1.55(1.08,2.05),均P<0.05],乳酸清除率更高[8小时为45%(27%,56%) vs. 20%(-4%,46%),24小时为55%(34%,70%) vs. 34%(-14%,59%),均P<0.05]。但复苏过程中两组液体复苏量﹑血管活性药物使用量及氧合指数差异无统计学意义。多因素Logistic回归分析显示,体重指数(BMI)与90天死亡率独立相关[比值比(OR)=1.991,95%置信区间(95%CI)为1.023 - 3.387,P = 0.043]。
早期脓毒症和脓毒性休克患者使用平衡晶体液和平衡晶体液联合白蛋白复苏时,血浆syndecan-1水平无显著差异,对患者28天和90天预后、住院时间、并发症等方面的影响也无统计学意义。然而,与平衡晶体液相比,脓毒症患者液体复苏时平衡晶体液联合白蛋白可降低乳酸水平,乳酸清除效果更好,但仍需通过大规模随机对照试验进一步验证。