Cooper Andrew B, Cohn Stephen M, Zhang Haibo S, Hanna Kim, Stewart Thomas E, Slutsky Arthur S
Department of Critical Care Medicine, Sunnybrook and Women's College Health Science Center, North York, Ontario, Canada.
Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.
The effect of 5 percent human albumin on multiple organ dysfunction was investigated during the first 14 days of treatment to determine whether albumin resuscitation might benefit adult burn patients.
Multicenter unblinded controlled trial with stratified block (two patients per block) randomization by center and mortality prediction at enrollment (high-risk stratum [predicted mortality, 50%-90%] and low-risk stratum [predicted mortality, <50%]). The primary outcome was the worst multiple organ dysfunction score (MODS), excluding the cardiovascular component, to Day 14. Eligible adults (>15 years) suffering from thermal injury not more than 12 hours before enrollment received fluid resuscitation with Ringer's lactate (n=23) or 5 percent human albumin plus Ringer's lactate (n=19) by protocol to achieve recommended (American Burn Association) resuscitation endpoints.
Forty-two patients were randomly assigned. There were no significant differences (median [95% confidence intervals]) in age (36 [24-45] vs. 31 [25-39] years), burn size (39 [32-53] vs. 32 [26-34] total body surface area percentage), inhalation injury (n=12/19 vs. n=11/23), or baseline MODS (3 [1-5] vs. 1.5 [0-2]) between the treatment and control groups. In an intention-to-treat analysis, there was no significant difference between the treatment and control group in the lowest MODS from Day 0 to Day 14 (analysis of covariance, p=0.73).
Treatment with 5 percent albumin from Day 0 to Day 14 does not decrease the burden of MODS in adult burn patients.
在治疗的前14天研究了5%人白蛋白对多器官功能障碍的影响,以确定白蛋白复苏是否可能使成年烧伤患者受益。
多中心非盲对照试验,按中心进行分层区组(每组2例患者)随机分组,并在入组时进行死亡率预测(高危组[预测死亡率,50%-90%]和低危组[预测死亡率,<50%])。主要结局是至第14天排除心血管成分的最差多器官功能障碍评分(MODS)。符合条件的成年患者(>15岁)在入组前12小时内遭受热损伤,按方案接受乳酸林格液(n=23)或5%人白蛋白加乳酸林格液(n=19)进行液体复苏,以达到推荐的(美国烧伤协会)复苏终点。
42例患者被随机分组。治疗组和对照组在年龄(36[24-45]岁 vs. 31[25-39]岁)、烧伤面积(39[32-53]% vs. 32[26-34]%体表面积)、吸入性损伤(n=12/19 vs. n=11/23)或基线MODS(3[1-5] vs. 1.5[0-2])方面无显著差异(中位数[95%置信区间])。在意向性分析中,治疗组和对照组在第0天至第14天的最低MODS方面无显著差异(协方差分析,p=0.73)。
从第0天至第14天用5%白蛋白治疗不会降低成年烧伤患者的MODS负担。