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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| Authors: | 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 French Pulmonary Artery Catheter Study Group |
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| Affiliation: | Service de Réanimation Médicale (Drs Richard, Anguel, and Teboul) and Service de Santé Publique et Epidémiologie (Dr Warszawski), Hôpital de Bicêtre, Assistance Publique, Hôpitaux de Paris, Université Paris XI, Le Kremlin Bicêtre; Service de Réanimation Médicale, Hôpital Européen Georges Pompidou (Dr Deye), Service de Réanimation Médicale, Groupe Hospitalier Pitié-Salpétrière (Dr Combes), and Service de Pneumologie et Réanimation, Groupe Hospitalier Pitié-Salpétrière (Dr Lefort), Assistance Publique, Hôpitaux de Paris, Université Paris VI, Paris; Service de Réanimation Médicale, Centre Hospitalo-Universitaire A. Michallon, Grenoble (Dr Barnoud); Service de Réanimation, Centre Hospitalier Régional Orléans-La Source, Orléans (Dr Boulain); Service de Réanimation Médicale, Hôpital Henri-Mondor, Assistance Publique, Hôpitaux de Paris, Université Paris XII, Créteil (Dr Fartoukh and Brochard); Service de Réanimation Médicale, Hôpital Lariboisière, Assistance Publique, Hôpitaux de Paris, Université Paris VII, Paris (Dr Baud); Service de Réanimation Médicale, Hôpital Louis Mourier, Assistance Publique, Hôpitaux de Paris, Université Paris VII, Colombes (Dr Boyer), France. |
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| 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 agentsfree days; hospital, intensive care unit, and mechanical ventilationfree 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. |
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