Randomized trial of volume expansion with albumin or saline in children with severe malaria: Preliminary evidence of albumin benefit
Randomized trial of volume expansion with albumin or saline in children with severe malaria: Preliminary evidence of albumin benefit
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DOI：
10.1086/427505
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发表时间：
2005-02-15
影响因子：
11.8
通讯作者：
Levin, M
中科院分区：
文献类型：
--
作者：
Maitland, K;Pamba, A;Levin, M
背景。代谢性酸中毒是严重恶性疟疾儿童死亡的最佳预测指标；然而，其治疗存在治疗困境，因为酸中毒和血容量不足可能与昏迷共存，而昏迷可能与颅内压升高有关。我们推测，用白蛋白进行容量复苏可能会纠正酸中毒和血容量不足，并且与晶体液相比，诱发脑水肿的风险较低。在一项开放标签、随机、对照试验中，我们比较了肯尼亚严重疟疾儿童使用白蛋白和生理盐水进行复苏的安全性。方法。我们随机分配患有严重疟疾和代谢性酸中毒（碱缺乏，> 18 mmol/L）的儿童接受 4.5% 白蛋白或生理盐水的液体复苏。对照组（仅维持）仅包含碱缺乏< 15 mmol/L 的患者。主要结果指标是 8 小时时碱赤字减少的百分比。次要终点包括死亡、救援治疗的需要以及幸存者的神经系统后遗症。结果。在招募参加试验的 150 名儿童中，61 名接受生理盐水，56 名接受白蛋白，33 名作为对照受试者。各组之间酸中毒的缓解没有显着差异；然而，接受白蛋白治疗的患者（3.6% [56 名患者中的 2 名]）死亡率明显低于接受生理盐水治疗的患者（18% [61 名患者中的 11 名]；相对风险，5.5；95% 置信区间，1.2 - 24.8；P = .014）。结论。对于患有严重疟疾和酸中毒的高危儿童，使用白蛋白进行液体复苏可能会降低死亡率。我们的研究设计无法确定盐水给药是否优于液体限制，或者盐水给药是否实际上是危险的。在提出明确的治疗建议之前，需要进一步的研究来证实我们的发现。
Background. Metabolic acidosis is the best predictor of death in children with severe falciparum malaria; however, its treatment presents a therapeutic dilemma, because acidosis and hypovolemia may coexist with coma, which can be associated with elevated intracranial pressure. We postulated that volume resuscitation with albumin might correct acidosis and hypovolemia with a lower risk of precipitating cerebral edema than crystalloid. In an open-label, randomized, controlled trial, we compared the safety of resuscitation with albumin to saline in Kenyan children with severe malaria.Methods. We randomly assigned children with severe malaria and metabolic acidosis (base deficit, > 18 mmol/L) to receive fluid resuscitation with either 4.5% albumin or normal saline. A control ( maintenance only) group was only included for patients with a base deficit of < 15 mmol/L. The primary outcome measure was the percentage reduction in base deficit at 8 h. Secondary end points included death, the requirement for rescue therapies, and neurological sequelae in survivors.Results. Of 150 children recruited for the trial, 61 received saline, 56 received albumin, and 33 served as control subjects. There was no significant difference in the resolution of acidosis between the groups; however, the mortality rate was significantly lower among patients who received albumin (3.6% [2 of 56 patients]) than among those who received saline (18% [11 of 61]; relative risk, 5.5; 95% confidence interval, 1.2 - 24.8; P = .014).Conclusions. In high-risk children with severe malaria and acidosis, fluid resuscitation with albumin may reduce mortality. Our study design did not enable us to determine whether saline administration is preferable to fluid restriction or whether saline administration is actually hazardous. Further studies are needed to confirm our findings before definitive treatment recommendations can be made.