Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome - A randomized controlled trial
Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome - A randomized controlled trial
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DOI：
10.1001/jama.290.20.2713
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发表时间：
2003-11-26
影响因子：
120.7
通讯作者：
Teboul, JL
中科院分区：
文献类型：
--
作者：
Richard, C;Warszawski, J;Teboul, JL
许多医生认为肺动脉导管（PAC）对心肺功能障碍的诊断和治疗是有用的；然而，观察性研究表明它的使用可能是有害的。目的探讨急性呼吸窘迫综合征（acute respiratory distress syndrome， ARDS）及感染性休克患者早期使用PAC对预后的影响。设计、环境和患者：1999年1月30日至2001年6月29日，在法国的36个重症监护病房进行了一项多中心随机对照研究，676名18岁及以上符合休克、ARDS或两者标准的患者。患者被随机分配接受PAC （n=335）或不接受PAC （n=341）。治疗方法由每个医生自行决定。主要终点为28天死亡率。主要次要终点为第14天和第90天的死亡率；第14天无器官系统、肾脏支持和血管活性药物；住院、加护病房、无机械通气第28天。结果两组在基线时相似。在第14天，有或没有PAC的死亡率没有显著差异：49.9% vs 51.3%（死亡率相对风险[RR]， 0.97； 95%可信区间[CI]， 0.84-1.13； P= 0.70）；28天:59.4% vs 61.0% (RR, 0.97; 95%置信区间,0.86 - -1.10;P =正);或90:70.7% vs 72.0% (RR, 0.98; 95%置信区间,0.89 - -1.08;P点)。在第14天，有或没有PAC的器官系统无衰竭的平均（SD）天数（2.3 [3.6]vs 2.4[3.5]），肾脏支持（7.4 [6.0]vs 7.5[5.9]）和血管活性药物（3.8 [4.8]vs 3.9[4.9]）没有差异。在第28天，使用或不使用PAC的平均住院天数（0.9 [3.6]vs 0.9[3.3]）、重症监护病房（3.4 [6.8]vs 3.3[6.9]）或机械通气使用（5.2 [8.5]vs 5.0[8.5]）均无差异。结论休克、急性呼吸窘迫综合征（ARDS）患者早期使用PAC的临床处理对死亡率和发病率无显著影响。
Context Many physicians believe that the pulmonary artery catheter (PAC) is useful for the diagnosis and treatment of cardiopulmonary disturbances; however, observational studies suggest that its use may be harmful.Objective To determine the effects on outcome of the early use of a PAC in patients with shock mainly of septic origin, acute respiratory distress syndrome (ARDS), or both.Design, Setting, and Patients A multicenter randomized controlled study of 676 patients aged 18 years or older who fulfilled the standard criteria for shock, ARDS, or both conducted in 36 intensive care units in France from January 30, 1999, to June 29, 2001.Intervention Patients, were randomly assigned to either receive a PAC (n=335) or not (n=341). The treatment was left to the discretion of each individual physician.Main Outcome Measures The primary end point was mortality at 28 days. The principal secondary end points were day 14 and 90 mortality; day 14 organ system, renal support, and vasoactive agents-free days; hospital, intensive care unit, and mechanical ventilation-free days at day 28.Results The 2 groups were similar at baseline. There were no significant differences in mortality with or without the PAC at day 14: 49.9% vs 51.3% (mortality relative risk [RR], 0.97; 95% confidence interval [CI], 0.84-1.13; P=.70); day 28: 59.4% vs 61.0% (RR, 0.97; 95% CI, 0.86-1.10; P=.67); or day 90:70.7% vs 72.0% (RR, 0.98; 95% CI, 0.89-1.08; P-.71). At day 14, the mean (SD) number of days free of organ system failures with or without the PAC (2.3 [3.6] vs 2.4 [3.5]), renal support (7.4 [6.0] vs 7.5 [5.9]), and vasoactive agents (3.8 [4.8] vs 3.9 [4.9]) did not differ. At day 28, mean (SD) days in hospital with or without the PAC (0.9 [3.6] vs 0.9 [3.3]), in the intensive care unit (3.4 [6.8] vs 3.3 [6.9]), or mechanical ventilation use (5.2 [8.5] vs 5.0 [8.5]) did not differ.Conclusion Clinical management involving the early use of a PAC in patients with shock, ARDS, or both did not significantly affect mortality and morbidity.