A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients - PubMed (original) (raw)

Clinical Trial

. 2003 Jan 2;348(1):5-14.

doi: 10.1056/NEJMoa021108.

Russell Douglas Hull, Rollin Frederick Brant, Linda Knox, Graham Frederick Pineo, Christopher J Doig, Denny P Laporta, Sidney Viner, Louise Passerini, Hugh Devitt, Ann Kirby, Michael Jacka; Canadian Critical Care Clinical Trials Group

Affiliations

• PMID: 12510037
• DOI: 10.1056/NEJMoa021108

Free article

Clinical Trial

A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients

James Dean Sandham et al. N Engl J Med. 2003.

Free article

Abstract

Background: Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality.

Methods: We performed a randomized trial comparing goal-directed therapy guided by a pulmonary-artery catheter with standard care without the use of a pulmonary-artery catheter. The subjects were high-risk patients 60 years of age or older, with American Society of Anesthesiologists (ASA) class III or IV risk, who were scheduled for urgent or elective major surgery, followed by a stay in an intensive care unit. Outcomes were adjudicated by 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) underwent randomization. The base-line characteristics of the two treatment groups were similar. A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter (7.7 percent) died in the hospital, as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used (7.8 percent)--a difference of 0.1 percentage point (95 percent confidence interval, -2.3 to 2.5). There was a higher rate of pulmonary embolism in the catheter group than in the standard-care group (8 events vs. 0 events, P=0.004). The survival rates at 6 months among patients in the standard-care and catheter groups were 88.1 and 87.4 percent, respectively (difference, -0.7 percentage point [95 percent confidence interval, -3.6 to 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 confidence interval, -4.3 to 2.4]). The median hospital stay was 10 days in each group.

Conclusions: We found no benefit to therapy directed by pulmonary-artery catheter over standard care in elderly, high-risk surgical patients requiring intensive care.

Copyright 2003 Massachusetts Medical Society

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Comment in

• Progress in research on pulmonary-artery catheters.
  Parsons PE. Parsons PE. N Engl J Med. 2003 Jan 2;348(1):66-8. doi: 10.1056/NEJMe020159. N Engl J Med. 2003. PMID: 12510046 No abstract available.
• The use of pulmonary artery catheters.
  Roitberg B. Roitberg B. Surg Neurol. 2003 Mar;59(3):145-6. doi: 10.1016/s0090-3019(03)00073-9. Surg Neurol. 2003. PMID: 12681533 No abstract available.
• Pulmonary-artery catheters in high-risk surgical patients.
  Cholley BP, Payen D. Cholley BP, et al. N Engl J Med. 2003 May 15;348(20):2035-7; author reply 2035-7. doi: 10.1056/NEJM200305153482019. N Engl J Med. 2003. PMID: 12748323 No abstract available.
• Pulmonary-artery catheters in high-risk surgical patients.
  Schwann NM, Mangano DT; Multicenter Study of Perioperative Ischemia Research Group. Schwann NM, et al. N Engl J Med. 2003 May 15;348(20):2035-7; author reply 2035-7. N Engl J Med. 2003. PMID: 12751469 No abstract available.
• Pulmonary-artery catheters in high-risk surgical patients.
  Karkouti K, Wijeysundera DN, Beattie SW. Karkouti K, et al. N Engl J Med. 2003 May 15;348(20):2035-7; author reply 2035-7. N Engl J Med. 2003. PMID: 12751470 No abstract available.
• Therapy guided by pulmonary-artery catheter for high-risk surgical patients was not better than standard care.
  Huang DT, Angus DC. Huang DT, et al. ACP J Club. 2003 Nov-Dec;139(3):66. ACP J Club. 2003. PMID: 14594417 No abstract available.
• Catheters and the treatment of acute lung injury.
  Tornero-Campello G. Tornero-Campello G. N Engl J Med. 2006 Aug 31;355(9):957-8; author reply 958. N Engl J Med. 2006. PMID: 16948187 No abstract available.

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