A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients
James Dean Sandham, M.D., Russell Douglas Hull, M.B., B.S., Rollin Frederick Brant, Ph.D., Linda Knox, R.N., Graham Frederick Pineo, M.D., Christopher J. Doig, M.D., Denny P. Laporta, M.D., Sidney Viner, M.D., Louise Passerini, M.D., Hugh Devitt, M.D., Ann Kirby, M.D., Michael Jacka, M.D., for the Canadian Critical Care Clinical Trials Group
Background Some observational studies suggest that the use ofpulmonary-artery catheters to guide therapy is associated withincreased mortality.
Methods We performed a randomized trial comparing goal-directedtherapy guided by a pulmonary-artery catheter with standardcare without the use of a pulmonary-artery catheter. The subjectswere high-risk patients 60 years of age or older, with AmericanSociety of Anesthesiologists (ASA) class III or IV risk, whowere scheduled for urgent or elective major surgery, followedby a stay in an intensive care unit. Outcomes were adjudicatedby observers who were unaware of the treatment-group assignments.The primary outcome was in-hospital mortality from any cause.
Results Of 3803 eligible patients, 1994 (52.4 percent) underwentrandomization. The base-line characteristics of the two treatmentgroups were similar. A total of 77 of 997 patients who underwentsurgery without the use of a pulmonary-artery catheter (7.7percent) died in the hospital, as compared with 78 of 997 patientsin whom a pulmonary-artery catheter was used (7.8 percent) a difference of 0.1 percentage point (95 percent confidenceinterval, 2.3 to 2.5). There was a higher rate of pulmonaryembolism in the catheter group than in the standard-care group(8 events vs. 0 events, P=0.004). The survival rates at 6 monthsamong patients in the standard-care and catheter groups were88.1 and 87.4 percent, respectively (difference, 0.7percentage point [95 percent confidence interval, 3.6to 2.2]; negative survival differences favor standard care);at 12 months, the rates were 83.9 and 83.0 percent, respectively(difference, 0.9 percentage point [95 percent confidenceinterval, 4.3 to 2.4]). The median hospital stay was10 days in each group.
Conclusions We found no benefit to therapy directed by pulmonary-arterycatheter over standard care in elderly, high-risk surgical patientsrequiring intensive care.
Source Information
From the Faculty of Medicine, University of Calgary, Calgary, Alta. (J.D.S., R.D.H., R.F.B., L.K., G.F.P., C.J.D., S.V., A.K.); the Sir Mortimer B. Davis Jewish General Hospital, Montreal (D.P.L.); the Faculty of Medicine, University of Montreal, Montreal (L.P.); the Faculty of Medicine, Dalhousie University, Halifax, N.S. (H.D.); and the University of Alberta, Edmonton (M.J.) all in Canada.
Address reprint requests to Dr. Sandham at the Department of Critical Care Medicine, EG23 Foothills St. NW, Calgary, AB T2N 2T9, Canada, or at sandham{at}ucalgary.ca.
Pulmonary-Artery Catheters in High-Risk Surgical Patients
Cholley B. P., Payen D., Karkouti K., Wijeysundera D. N., Beattie S. W., Schwann N. M., Mangano D. T., the Multicenter Study of Perioperative Ischemia Research Group , Sandham J. D., Hull R. D., Brant R. F.
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N Engl J Med 2003;
348:2035-2037, May 15, 2003.
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