High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial
High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial
复制标题
DOI：
10.1007/s00134-013-2967-z
复制
发表时间：
2013-09-01
影响因子：
38.9
通讯作者：
Ouattara, Alexandre
中科院分区：
文献类型：
--
作者：
Joannes-Boyau, Olivier;Honore, Patrick M.;Ouattara, Alexandre
感染性休克是危重患者死亡的主要原因，特别是合并急性肾损伤（AKI）时。小型实验和人体临床研究表明，高容量血液滤过（HVHF）可能改善血液动力学特征和死亡率。我们试图确定HVHF对感染性休克和AKI危重患者28天死亡率的影响。这是一项前瞻性、随机、开放、多中心临床试验，在法国、比利时和荷兰的18个重症监护室进行。从2005年10月至2010年3月，共有140名脓毒性休克和AKI持续时间小于24小时的危重患者入组。患者随机分为70 mL/kg/h的HVHF组和35 mL/kg/h的标准容量血液滤过（SVHF）组，为期96小时。主要终点为28天死亡率。在140名患者入组后，由于患者累积缓慢和资源不再可用，该试验过早停止。共分析137例患者（2例撤回同意，1例被排除）；HVHF组66例，SVHF组71例。28天死亡率低于预期，但组间无差异（HVHF 37.9% vs SVHF 40.8%， log-rank检验p = 0.94）。两组间的次要终点均无统计学差异。在科特迪瓦的试验中，没有证据表明70 mL/kg/h的HVHF与35 mL/kg/h的当代SVHF相比，可降低28天死亡率或有助于血液动力学特征或器官功能的早期改善。本试验中应用的HVHF不能被推荐用于脓毒性休克并发AKI的治疗。
Septic shock is a leading cause of death among critically ill patients, in particular when complicated by acute kidney injury (AKI). Small experimental and human clinical studies have suggested that high-volume haemofiltration (HVHF) may improve haemodynamic profile and mortality. We sought to determine the impact of HVHF on 28-day mortality in critically ill patients with septic shock and AKI.This was a prospective, randomized, open, multicentre clinical trial conducted at 18 intensive care units in France, Belgium and the Netherlands. A total of 140 critically ill patients with septic shock and AKI for less than 24 h were enrolled from October 2005 through March 2010. Patients were randomized to either HVHF at 70 mL/kg/h or standard-volume haemofiltration (SVHF) at 35 mL/kg/h, for a 96-h period.Primary endpoint was 28-day mortality. The trial was stopped prematurely after enrolment of 140 patients because of slow patient accrual and resources no longer being available. A total of 137 patients were analysed (two withdrew consent, one was excluded); 66 patients in the HVHF group and 71 in the SVHF group. Mortality at 28 days was lower than expected but not different between groups (HVHF 37.9 % vs. SVHF 40.8 %, log-rank test p = 0.94). There were no statistically significant differences in any of the secondary endpoints between treatment groups.In the IVOIRE trial, there was no evidence that HVHF at 70 mL/kg/h, when compared with contemporary SVHF at 35 mL/kg/h, leads to a reduction of 28-day mortality or contributes to early improvements in haemodynamic profile or organ function. HVHF, as applied in this trial, cannot be recommended for treatment of septic shock complicated by AKI.