Structured abstract
Question
In high-risk elderly patients undergoing surgery followed by a stay in the intensive care unit (ICU), is there a difference in perioperative outcomes when treatment is guided by a pulmonary artery catheter (PAC) compared to treatment without a PAC?
Design
Multicentre, randomized trial.
Setting
Nineteen centres in Canada.
Patients
One thousand, nine hundred and ninety-four patients were randomized between March 1990 and July 1999. Inclusion criteria were age > - 60 yr; American Society of Anesthesiologists physical status class III or IV; elective or urgent major abdominal, thoracic, vascular, or hip-fracture surgery; and a minimum ICU stay of 24 hr. Randomization was stratified to type of surgery and ASA class.
Intervention
Patients in the catheter group had a PAC inserted before surgery and treatment was directed to achieve the following goals (in descending priority): oxygen delivery index 550 to 660 mL·min−1·m−2 body surface area (BSA); cardiac index 3.5 to 4.5 L·min−1·m−2 BSA; mean arterial pressure 70 mmHg; pulmonary capillary wedge pressure 18 mmHg; heart rate < 120 beats·min−1; and hematocrit > 0.27. Patients in the standard therapy group were treated without a PAC; central venous catheterization was permitted. Patients and caregivers were not blinded to the interventions.
Main outcomes
In-hospital all-cause mortality was the primary outcome. Six-month mortality, 12-month mortality, and in-hospital morbidity (myocardial infarction, left ventricular failure, arrhythmia, pneumonia, pulmonary embolism, renal insufficiency, hepatic insufficiency, and sepsis from central venous or pulmonary artery catheters) were the secondary outcomes. All outcomes except death were reviewed by two blinded outcome adjudicators.
Main results
Analysis was intention-to-treat. Of the 997 patients in each group, 939 patients in the catheter group and 945 patients in the standard therapy group received the assigned intervention. There was no difference in in-hospital mortality, six-month mortality, 12-month mortality, or in-hospital morbidity with the exception of pulmonary embolism (Table). Incidence of pulmonary embolism was higher in the catheter group (0.9%) compared to the standard therapy group (0.0%,P= 0.004).
Conclusion
Goal-directed therapy with a PAC did not decrease mortality or postoperative morbidity compared to standard therapy without a PAC.
Funding
Canadian Institute for Health Research and Abbott Laboratories of Canada.
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Bryson, G.L., Yang, H. Best evidence in anesthetic practice Goal-directed therapy with the pulmonary artery catheter is not better than standard therapy. Can J Anesth 50, 614–616 (2003). https://doi.org/10.1007/BF03018652
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DOI: https://doi.org/10.1007/BF03018652