Mortality after Fluid Bolus in African Children with Severe Infection
Mortality after Fluid Bolus in African Children with Severe Infection
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DOI：
10.1056/nejmoa1101549
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发表时间：
2011-06-30
影响因子：
158.5
通讯作者：
Gibb, Diana M.
中科院分区：
文献类型：
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作者：
Maitland, Kathryn;Kiguli, Sarah;Gibb, Diana M.
背景液体复苏在治疗生活在资源有限的休克和危及生命的感染儿童中的作用尚未确定。方法我们随机分配患有严重发热和血流灌注受损的儿童，在乌干达、肯尼亚或坦桑尼亚(A层)的医院入院时，随机分配到每公斤体重给予20~40毫升5%白蛋白溶液(白蛋白团注组)或0.9%生理盐水(生理盐水团注组)(对照组)；患有严重低血压的儿童被随机分配到其中一组(B层)。根据指南，所有儿童都接受了适当的抗菌治疗、静脉维持液和支持性护理。有营养不良或胃肠炎的儿童被排除在外。主要终点是48小时的死亡率；次要终点是肺水肿、颅内压升高，以及4周后的死亡率或神经后遗症。结果数据和安全监测委员会建议在A层3600名儿童中的3141名招募后停止招募。疟疾状况(总的57%)和临床严重程度在不同组之间相似。白蛋白丸组、生理盐水丸组和对照组的48小时死亡率分别为10.6%(111/1050儿童)、10.5%(110/1047儿童)和7.3%(76/1044儿童)(生理盐水丸组相对危险度1.44；95%可信区间1.09~1.90；P=0.01；白蛋白丸组相对危险度1.01；95%可信区间0.78~1.29；P=0.96；与对照组相比，任何给药的相对危险度为1.45；95%可信区间为1.13至1.86；P=0.003)。3组4周病死率分别为12.2%、12.0%、8.7%(给药组与对照组比较P=0.004)。神经后遗症发生率分别为2.2%、1.9%和2.0%(P=0.92)，肺水肿和颅内压升高发生率分别为2.6%、2.2%和1.7%(P=0.17)。在B层，蛋白丸组69%(9/13)和生理盐水组56%(9/16)死亡(P=0.45)。根据休克的严重程度和疟疾、昏迷、败血症、酸中毒和严重贫血的状况，跨中心和跨亚组的结果是一致的。结论在非洲这些资源有限的环境中，SFLUID丸剂显著增加了血流灌注受损的危重儿童的48小时死亡率。(由英国医学研究理事会资助；FEAST当前对照试验编号，ISRCTN69856593。)
BACKGROUNDThe role of fluid resuscitation in the treatment of children with shock and life-threatening infections who live in resource-limited settings is not established.METHODSWe randomly assigned children with severe febrile illness and impaired perfusion to receive boluses of 20 to 40 ml of 5% albumin solution (albumin-bolus group) or 0.9% saline solution (saline-bolus group) per kilogram of body weight or no bolus (control group) at the time of admission to a hospital in Uganda, Kenya, or Tanzania (stratum A); children with severe hypotension were randomly assigned to one of the bolus groups only (stratum B). All children received appropriate antimicrobial treatment, intravenous maintenance fluids, and supportive care, according to guidelines. Children with malnutrition or gastroenteritis were excluded. The primary end point was 48-hour mortality; secondary end points included pulmonary edema, increased intracranial pressure, and mortality or neurologic sequelae at 4 weeks.RESULTSThe data and safety monitoring committee recommended halting recruitment after 3141 of the projected 3600 children in stratum A were enrolled. Malaria status (57% overall) and clinical severity were similar across groups. The 48-hour mortality was 10.6% (111 of 1050 children), 10.5% (110 of 1047 children), and 7.3% (76 of 1044 children) in the albumin-bolus, saline-bolus, and control groups, respectively (relative risk for saline bolus vs. control, 1.44; 95% confidence interval [CI], 1.09 to 1.90; P = 0.01; relative risk for albumin bolus vs. saline bolus, 1.01; 95% CI, 0.78 to 1.29; P = 0.96; and relative risk for any bolus vs. control, 1.45; 95% CI, 1.13 to 1.86; P = 0.003). The 4-week mortality was 12.2%, 12.0%, and 8.7% in the three groups, respectively (P = 0.004 for the comparison of bolus with control). Neurologic sequelae occurred in 2.2%, 1.9%, and 2.0% of the children in the respective groups (P = 0.92), and pulmonary edema or increased intracranial pressure occurred in 2.6%, 2.2%, and 1.7% (P = 0.17), respectively. In stratum B, 69% of the children (9 of 13) in the albuminbolus group and 56% (9 of 16) in the saline-bolus group died (P = 0.45). The results were consistent across centers and across subgroups according to the severity of shock and status with respect to malaria, coma, sepsis, acidosis, and severe anemia.CONCLUSIONSFluid boluses significantly increased 48-hour mortality in critically ill children with impaired perfusion in these resource-limited settings in Africa. (Funded by the Medical Research Council, United Kingdom; FEAST Current Controlled Trials number, ISRCTN69856593.)