Out-of-hospital Hypertonic Resuscitation After Traumatic Hypovolemic Shock A Randomized, Placebo Controlled Trial
Out-of-hospital Hypertonic Resuscitation After Traumatic Hypovolemic Shock A Randomized, Placebo Controlled Trial
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DOI：
10.1097/sla.0b013e3181fcdb22
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发表时间：
2011-03-01
影响因子：
9
通讯作者：
Hoyt, David B.
中科院分区：
文献类型：
--
作者：
Bulger, Eileen M.;May, Susanne;Hoyt, David B.
目的：为了确定院外给予高渗液体是否会改善严重创伤伴出血性休克患者的存活率。背景：高渗液体在严重创伤患者的复苏中具有潜在的益处，因为它可以快速恢复组织灌注，体积较小，并调节炎症反应，以减少随后的器官损伤。多中心、随机、盲法临床试验，2006年5月至2008年8月，复苏结局联盟内北美114家紧急医疗服务机构。入选标准：受伤患者，年龄>= 15岁，低血容量性休克（收缩压= 108次/分钟）。初始复苏液，由院外提供者给予250 mL 7.5%生理盐水/6%右旋糖酐70（高渗盐水/右旋糖酐，HSD）、7.5%生理盐水（高渗盐水，HS）或0.9%生理盐水（生理盐水，NS）。主要结局是28天生存率。根据数据和安全监测委员会的建议，该研究因无效和潜在的安全性问题而提前停止（占拟定样本量的23%）。结果：共纳入853例治疗患者，其中62%为钝性创伤，38%为穿透性创伤。28天生存率无差异-HSD：74.5%（0.1; 95%置信区间[CI]，-7.5至7.8）; HS：73.0%（-1.4; 95% CI，-8.7至6.0）; NS：74.4%，P = 0.91。与NS组相比，随机化后24小时内未接受输血、接受高渗液体的患者亚组的死亡率更高[28天死亡率-HSD：10%（5.2; 95%CI，0.4-10.1）; HS：12.2%（7.4; 95%CI，2.5-12.2）; NS：4.8%，P < 0.01]。结论：在低血容量性休克的受伤患者中，与NS相比，HS或HSD的初始复苏液体治疗并未导致上级28天生存率。然而，由于试验提前停止，对这些结果的解释受到限制。
Objective: To determine whether out-of-hospital administration of hypertonic fluids would improve survival after severe injury with hemorrhagic shock.Background: Hypertonic fluids have potential benefit in the resuscitation of severely injured patients because of rapid restoration of tissue perfusion, with a smaller volume, and modulation of the inflammatory response, to reduce subsequent organ injury.Methods: Multicenter, randomized, blinded clinical trial, May 2006 to August 2008, 114 emergency medical services agencies in North America within the Resuscitation Outcomes Consortium. Inclusion criteria: injured patients, age >= 15 years with hypovolemic shock (systolic blood pressure = 108 beats per minute). Initial resuscitation fluid, 250 mL of either 7.5% saline per 6% dextran 70 (hypertonic saline/dextran, HSD), 7.5% saline (hypertonic saline, HS), or 0.9% saline (normal saline, NS) administered by out-of-hospital providers. Primary outcome was 28-day survival. On the recommendation of the data and safety monitoring board, the study was stopped early (23% of proposed sample size) for futility and potential safety concern.Results: A total of 853 treated patients were enrolled, among whom 62% were with blunt trauma, 38% with penetrating. There was no difference in 28-day survival-HSD: 74.5% (0.1; 95% confidence interval [CI], -7.5 to 7.8); HS: 73.0% (-1.4; 95% CI, -8.7-6.0); and NS: 74.4%, P = 0.91. There was a higher mortality for the postrandomization subgroup of patients who did not receive blood transfusions in the first 24 hours, who received hypertonic fluids compared to NS [28-day mortality-HSD: 10% (5.2; 95% CI, 0.4-10.1); HS: 12.2% (7.4; 95% CI, 2.5-12.2); and NS: 4.8%, P < 0.01].Conclusion: Among injured patients with hypovolemic shock, initial resuscitation fluid treatment with either HS or HSD compared with NS, did not result in superior 28-day survival. However, interpretation of these findings is limited by the early stopping of the trial.