肺动脉导管的早期使用与休克和急性呼吸窘迫综合征患者的预后：一项随机对照试验。

Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome: a randomized controlled trial.

作者信息

Richard Christian, Warszawski Josiane, Anguel Nadia, Deye Nicolas, Combes Alain, Barnoud Didier, Boulain Thierry, Lefort Yannick, Fartoukh Muriel, Baud Frederic, Boyer Alexandre, Brochard Laurent, Teboul Jean-Louis

机构信息

Service de Réanimation Médicale, Hôpital de Bicêtre, Le Kremlin Bicêtre, France.

出版信息

JAMA. 2003 Nov 26;290(20):2713-20. doi: 10.1001/jama.290.20.2713.

DOI:10.1001/jama.290.20.2713

PMID:14645314

Abstract

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.

摘要

背景

许多医生认为肺动脉导管（PAC）对心肺功能紊乱的诊断和治疗有用；然而，观察性研究表明其使用可能有害。

目的

确定早期使用PAC对主要由脓毒症引起的休克、急性呼吸窘迫综合征（ARDS）或两者兼具的患者预后的影响。

设计、地点和患者：一项多中心随机对照研究，对1999年1月30日至2001年6月29日在法国36个重症监护病房中676例年龄18岁及以上、符合休克、ARDS或两者标准的患者进行研究。

干预措施

患者被随机分配接受PAC（n = 335）或不接受PAC（n = 341）。治疗由每位医生自行决定。

主要结局指标

主要终点是28天死亡率。主要次要终点是第14天和90天死亡率；第14天无器官系统衰竭、肾脏支持和血管活性药物使用的天数；第28天无住院、无重症监护病房和无机械通气的天数。

结果

两组在基线时相似。第14天使用或未使用PAC的死亡率无显著差异：49.9%对51.3%（死亡相对风险[RR]，0.97；95%置信区间[CI]，0.84 - 1.13；P = 0.70）；第28天：59.4%对61.0%（RR，0.97；95% CI，0.86 - 1.10；P = 0.67）；或第90天：70.7%对72.0%（RR，0.98；95% CI，0.89 - 1.08；P = 0.71）。在第14天，使用或未使用PAC时无器官系统衰竭的平均（标准差）天数（2.3 [3.6]对2.4 [3.5]）、肾脏支持天数（7.4 [6.0]对7.5 [5.9]）和血管活性药物使用天数（3.8 [4.8]对3.9 [4.9]）无差异。在第28天，使用或未使用PAC时的平均（标准差）住院天数（0.9 [3.6]对0.9 [3.3]）、重症监护病房天数（3.4 [6.8]对3.3 [6.9]）或机械通气使用天数（5.2 [8.5]对5.0 [8.5]）无差异。