Brooke Army Medical Center, Fort Sam Houston, TX, USA.
Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Crit Care. 2017 Nov 25;21(1):289. doi: 10.1186/s13054-017-1878-8.
Sepsis and septic shock occur commonly in severe burns. Acute kidney injury (AKI) is also common and often results as a consequence of sepsis. Mortality is unacceptably high in burn patients who develop AKI requiring renal replacement therapy and is presumed to be even higher when combined with septic shock. We hypothesized that high-volume hemofiltration (HVHF) as a blood purification technique would be beneficial in this population.
We conducted a multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of HVHF on the hemodynamic profile of burn patients with septic shock and AKI involving seven burn centers in the United States. Subjects randomized to the HVHF were prescribed a dose of 70 ml/kg/hour for 48 hours while control subjects were managed in standard fashion in accordance with local practices.
During a 4-year period, a total of nine subjects were enrolled for the intervention during the ramp-in phase and 28 subjects were randomized, 14 each into the control and HVHF arms respectively. The study was terminated due to slow enrollment. Ramp-in subjects were included along with those randomized in the final analysis. Our primary endpoint, the vasopressor dependency index, decreased significantly at 48 hours compared to baseline in the HVHF group (p = 0.007) while it remained no different in the control arm. At 14 days, the multiple organ dysfunction syndrome score decreased significantly in the HVHF group when compared to the day of treatment initiation (p = 0.02). No changes in inflammatory markers were detected during the 48-hour intervention period. No significant difference in survival was detected. No differences in adverse events were noted between the groups.
HVHF was effective in reversing shock and improving organ function in burn patients with septic shock and AKI, and appears safe. Whether reversal of shock in these patients can improve survival is yet to be determined.
Clinicaltrials.gov NCT01213914 . Registered 30 September 2010.
败血症和感染性休克在严重烧伤中很常见。急性肾损伤（AKI）也很常见，通常是败血症的后果。需要肾脏替代治疗的烧伤患者发生 AKI 时死亡率非常高，并且当合并感染性休克时死亡率更高。我们假设高容量血液滤过（HVHF）作为一种血液净化技术对这种人群有益。
我们进行了一项多中心、前瞻性、随机、对照临床试验，以评估 HVHF 对伴有 AKI 的感染性休克烧伤患者血流动力学特征的影响，该试验涉及美国的 7 个烧伤中心。随机分配到 HVHF 组的患者接受 70ml/kg/h 的剂量治疗 48 小时，而对照组则按照当地的常规进行治疗。
在 4 年的时间里，共有 9 名受试者在 ramp-in 阶段接受了干预，共有 28 名受试者被随机分配到对照组和 HVHF 组，每组 14 名。由于入组缓慢，该研究提前终止。ramp-in 受试者与最终分析中的随机受试者一起纳入分析。我们的主要终点，血管加压药依赖性指数，在 HVHF 组 48 小时与基线相比显著下降（p=0.007），而对照组没有变化。在 14 天时，HVHF 组的多器官功能障碍综合征评分与治疗开始时相比显著降低（p=0.02）。在 48 小时的干预期间，未检测到炎症标志物的变化。未检测到两组之间的生存率差异。两组之间未观察到不良事件的差异。
HVHF 可有效逆转休克并改善败血症和 AKI 烧伤患者的器官功能，且似乎安全。这些患者的休克逆转是否能提高生存率还有待确定。
Clinicaltrials.gov NCT01213914。注册于 2010 年 9 月 30 日。
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