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Effect of Transfusion of Red Blood Cells With Longer vs Shorter Storage Duration on Elevated Blood Lactate Levels in Children With Severe Anemia: The TOTAL Randomized Clinical Trial.
输注储存时间较长与较短的红细胞对重度贫血患儿血乳酸水平升高的影响: 完全随机临床试验。

摘要

IMPORTANCE:Although millions of transfusions are given annually worldwide, the effect of red blood cell (RBC) unit storage duration on oxygen delivery is uncertain.
OBJECTIVE:To determine if longer-storage RBC units are not inferior to shorter-storage RBC units for tissue oxygenation as measured by reduction in blood lactate levels and improvement in cerebral tissue oxygen saturation among children with severe anemia.
DESIGN, SETTING, AND PARTICIPANTS:Randomized noninferiority trial of 290 children (aged 6-60 months), most with malaria or sickle cell disease, presenting February 2013 through May 2015 to a university-affiliated national referral hospital in Kampala, Uganda, with a hemoglobin level of 5 g/dL or lower and a lactate level of 5 mmol/L or higher.
INTERVENTIONS:Patients were randomly assigned to receive RBC units stored 25 to 35 days (longer-storage group; n = 145) vs 1 to 10 days (shorter-storage group; n = 145). All units were leukoreduced prior to storage. All patients received 10 mL/kg of RBCs during hours 0 through 2 and, if indicated per protocol, an additional 10 mL/kg during hours 4 through 6.
MAIN OUTCOMES AND MEASURES:The primary outcome was the proportion of patients with a lactate level of 3 mmol/L or lower at 8 hours using a margin of noninferiority equal to an absolute difference of 25%. Secondary measures included noninvasive cerebral tissue oxygen saturation during the first transfusion, clinical and laboratory changes up to 24 hours, and survival and health at 30 days after transfusion. Adverse events were monitored up to 24 hours.
RESULTS:In the total population of 290 children, the mean (SD) presenting hemoglobin level was 3.7 g/dL (1.3) and mean lactate level was 9.3 mmol/L (3.4). Median (interquartile range) RBC unit storage was 8 days (7-9) for shorter storage vs 32 days (30-34) for longer storage without overlap. The proportion achieving the primary end point was 0.61 (95% CI, 0.52 to 0.69) in the longer-storage group vs 0.58 (95% CI, 0.49 to 0.66) in the shorter-storage group (between-group difference, 0.03 [95% CI, -0.07 to ∞], P < .001), meeting the prespecified margin of noninferiority. Mean lactate levels were not statistically different between the 2 groups at 0, 2, 4, 6, 8, or 24 hours. Kaplan-Meier analysis and global nonlinear regression revealed no statistical difference in lactate reduction between the 2 groups. Clinical assessment, cerebral oxygen saturation, electrolyte abnormalities, adverse events, survival, and 30-day recovery were also not significantly different between the groups.
CONCLUSIONS AND RELEVANCE:Among children with lactic acidosis due to severe anemia, transfusion of longer-storage compared with shorter-storage RBC units did not result in inferior reduction of elevated blood lactate levels. These findings have relevance regarding the efficacy of stored RBC transfusion for patients with critical tissue hypoxia and lactic acidosis due to anemia.
TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01586923.

译文

重要性: 尽管全世界每年有数百万次输血,但红细胞 (RBC) 单位储存时间对氧气输送的影响还不确定。
目标: 为了确定长期储存的红细胞单位在组织氧合方面是否不逊于短期储存的红细胞单位,这是通过降低血乳酸水平和改善严重贫血儿童的脑组织血氧饱和度来衡量的。。
设计、背景和参与者: 针对 290 名儿童 (年龄 6-60 个月) 的随机非劣效性试验,大多数患有疟疾或镰状细胞病, 2013年2月至 2015年5月在乌干达坎帕拉的一家大学附属国家转诊医院就诊,血红蛋白水平为 5g/dL 或更低,乳酸水平为 5 mmol/L 或更高。
干预: 病人被随机分配接受储存了 25 到 35 天的红细胞单位 (较长储存组; n = 145) vs 1 到 10 天 (较短储存组; n = 145)。所有单位在储存前都有白细胞减少。所有患者在 0 至 2 小时内接受 10 毫升/千克的红细胞,如果根据协议,在 4 至 6 小时内额外接受 10 毫升/千克的红细胞。
主要结果和措施: 主要结果是在 8 小时内乳酸水平为 3 mmol/L 或更低的患者比例,使用的非劣效率等于 25% 的绝对差异。次要指标包括首次输血时的无创脑组织氧饱和度、长达 24 小时的临床和实验室变化,以及输血后 30 天的生存和健康。监测不良事件长达 24 小时。
结果: 在 290 名儿童的总人口中,平均血红蛋白水平为 3.7g/dL (1.3),平均乳酸水平为 9.3 mmol/L (3.4)。中位数 (四分位范围) RBC 单位储存时间较短的为 8 天 (7-9),而无重叠的较长储存时间为 32 天 (30-34)。在较长存储组中,达到主要终点的比例为 0.61 (95% CI,0.52 至 0.69),而在 0.58 (95% CI,0.49 至 0.66) 在短存储组 (组间差异,0.03 [95% CI,-0.07 至 ∞],p ¼ <¼。 001),满足预先确定的非劣效性。在 0 、 2 、 4 、 6 、 8 或 24 小时,两组之间的平均乳酸水平没有统计学差异。Kaplan-Meier 分析和全局非线性回归显示两组之间乳酸降低没有统计学差异。临床评估、脑氧饱和度、电解质异常、不良事件、生存率和 30 天恢复在两组之间也没有显著差异。
结论和相关性: 在严重贫血导致的乳酸酸中毒儿童中,与短储存红细胞单位相比,长储存红细胞单位的输血不会导致血乳酸水平升高的低降低。这些发现与储存红细胞输血对贫血导致的临界组织缺氧和乳酸酸中毒患者的疗效相关。
试验注册: clinicaltrials.gov 标识符: nct01586923。

Blood lactate

重症 脓毒症 临床研究术语
概述  :  

基本信息血乳酸是血液检查的一个指标,是人体糖代谢的中间产物,主要由红细胞、横纹肌和脑组织产生,且浓度变化往往取决于肝脏及肾脏的合成速度和代谢率。。一般情况下乳酸增高多提示人体组织出现缺氧,以及葡萄糖代谢出现紊乱,比较常见的疾病是休克、心律失常、心衰、血液病、肺功能不全等,都会引起缺氧所导致的高乳酸血症。临床中另一个非常常见的疾病就是糖尿病乳酸中毒,在糖尿病患者中非常常见,需要合理的应用药物治疗。乳酸是反映组织缺血缺氧的敏感产物,可间接反映器官功能障碍和休克的发生发展。本次主要描述血乳酸与脓毒症之

Blood 英 [blʌd] 美 [blʌd]

释义   n. 血,血液;血统

vt. 从…抽血;使先取得经验

n. (Blood)人名;(英、西)布拉德

例句   Leukemia is a blood disease.白血病是一种血液病。

 

lactate 英 [lækˈteɪt] 美 [ˈlækteɪt]

释义   v. (妇女或雌性动物)泌乳,哺乳

n. 乳酸盐(或酯)

例句   Doctors use arterial blood gas analysis to determine the level of lactic acid in the patient's blood.医生通过动脉血气分析来得知患者体内血乳酸水平。


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