Effects of Fluid Resuscitation With Colloids vs Crystalloids on Mortality in Critically Ill Patients Presenting With Hypovolemic Shock The CRISTAL Randomized Trial
Effects of Fluid Resuscitation With Colloids vs Crystalloids on Mortality in Critically Ill Patients Presenting With Hypovolemic Shock The CRISTAL Randomized Trial
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DOI：
10.1001/jama.2013.280502
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发表时间：
2013-11-06
影响因子：
120.7
通讯作者：
Chevret, Sylvie
中科院分区：
文献类型：
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作者：
Annane, Djillali;Siami, Shidasp;Chevret, Sylvie
支持选择静脉注射胶体溶液还是晶体溶液治疗低血容量性休克的证据尚不清楚。目的：比较胶体与晶体在液体复苏中的应用是否能改变重症监护病房（ICU）低血容量性休克患者的死亡率。设计、环境和参与者：一项多中心、随机临床试验，按病例组合（脓毒症、创伤或无脓毒症或创伤的低血容量性休克）分层。在用于危重病人复苏的胶体与晶体（CRISTAL）试验中，治疗是开放标签的，但结果评估对治疗分配是盲目的。招募从2003年2月开始到2012年8月结束，共有2857名序贯ICU患者在法国、比利时、北非和加拿大的57个ICU接受治疗；随访于2012年11月结束。除整个ICU住院期间的液体维持外，所有液体干预均采用胶体（n = 1414；明胶、葡聚糖、羟乙基淀粉或4%或20%的白蛋白）或晶体（n = 1443；等渗或高渗生理盐水或乳酸林格溶液）。主要结局和测量主要结局为28天内死亡。次要结局包括90天死亡率；存活天数和未接受肾脏替代治疗、机械通气或血管加压治疗的天数。结果28 d内，胶体组死亡359例（25.4%），晶体组死亡390例（27.0%）（相对危险度[RR]， 0.96 [95% CI, 0.88 ~ 1.04]; P = 0.26）。90 d内，胶体组死亡434例（30.7%），晶体组死亡493例（34.2%）（RR, 0.92 [95% CI, 0.86 ~ 0.99]; P = 0.03）。胶体组156例（11.0%）接受肾脏替代治疗，晶体组181例（12.5%）接受肾脏替代治疗（RR, 0.93 [95% CI, 0.83 ~ 1.03]; P = 0.19）。有天活着没有机械通风的胶体组与晶体组由7天(分别代表:2.1 vs 1.8天,平均差,0.30(95%可信区间,0.09至0.48)天;P = . 01)和28天(平均:14.6 vs 13.5天,平均差,1.10(95%可信区间,0.14至2.06)天;P = . 01),活着没有血管加压的治疗7天(平均:5.0 vs 4.7天,平均差,0.30(95%可信区间,-0.03至0.50)天;P = .04点)和28天(意思是:16.2 vs 15.2天;平均差异为1.04 [95% CI, -0.04 ~ 2.10]天；P = .03)。在ICU低血容量患者中，胶体与晶体的使用在28天死亡率上没有显著差异。虽然接受胶体治疗的患者90天死亡率较低，但这一发现应被视为探索性的，在得出疗效结论之前需要进一步研究。
IMPORTANCE Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear.OBJECTIVE To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the intensive care unit (ICU) with hypovolemic shock.DESIGN, SETTING, AND PARTICIPANTS A multicenter, randomized clinical trial stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma). Therapy in the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial was open label but outcome assessment was blinded to treatment assignment. Recruitment began in February 2003 and ended in August 2012 of 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada; follow-up ended in November 2012.INTERVENTIONS Colloids (n = 1414; gelatins, dextrans, hydroxyethyl starches, or 4% or 20% of albumin) or crystalloids (n = 1443; isotonic or hypertonic saline or Ringer lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay.MAIN OUTCOMES AND MEASURES The primary outcome was death within 28 days. Secondary outcomes included 90-day mortality; and days alive and not receiving renal replacement therapy, mechanical ventilation, or vasopressor therapy.RESULTS Within 28 days, there were 359 deaths (25.4%) in colloids group vs 390 deaths (27.0%) in crystalloids group (relative risk [RR], 0.96 [95% CI, 0.88 to 1.04]; P = .26). Within 90 days, there were 434 deaths (30.7%) in colloids group vs 493 deaths (34.2%) in crystalloids group (RR, 0.92 [95% CI, 0.86 to 0.99]; P = .03). Renal replacement therapy was used in 156 (11.0%) in colloids group vs 181 (12.5%) in crystalloids group (RR, 0.93 [95% CI, 0.83 to 1.03]; P = .19). There were more days alive without mechanical ventilation in the colloids group vs the crystalloids group by 7 days (mean: 2.1 vs 1.8 days, respectively; mean difference, 0.30 [95% CI, 0.09 to 0.48] days; P = .01) and by 28 days (mean: 14.6 vs 13.5 days; mean difference, 1.10 [95% CI, 0.14 to 2.06] days; P = .01) and alive without vasopressor therapy by 7 days (mean: 5.0 vs 4.7 days; mean difference, 0.30 [95% CI, -0.03 to 0.50] days; P = .04) and by 28 days (mean: 16.2 vs 15.2 days; mean difference, 1.04 [95% CI, -0.04 to 2.10] days; P = .03).CONCLUSIONS AND RELEVANCE Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality. Although 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study before reaching conclusions about efficacy.