Pulmonary artery catheterization in high-risk surgery
Trial question
What is the role of goal-directed therapy guided by a pulmonary artery catheter in high-risk surgical patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 1994
1994 patients (576 female, 1418 male).
Inclusion criteria: high-risk adult patients aged ≥ 60 years who were scheduled for urgent or elective major surgery, followed by a stay in the ICU.
Key exclusion criteria: lack of available beds in the ICU; no informed consent; no referral by the treating physician.
Interventions
N=997 pulmonary artery catheter (goal-directed therapy guided by a pulmonary artery catheter).
N=997 no pulmonary artery catheter (standard of care without the use of a pulmonary artery catheter).
Primary outcome
Death in hospital
7.8%
7.7%
7.8 %
5.8 %
3.9 %
1.9 %
0.0 %
Pulmonary artery
catheter
No pulmonary artery
catheter
No significant
difference ↔
No significant difference in death in the hospital (7.8% vs. 7.7%; AD 0.1%, 95% CI -2.3 to 2.5).
Secondary outcomes
Borderline significant increase in length of hospital stay (10 days vs. 10 days).
Significant increase in PE (0.9% vs. 0%; AD 0.9%, 95% CI 0.29 to 1.51).
No significant difference in survival at 12 months (83% vs. 83.9%; ARD -0.9, 95% CI -4.3 to 2.4).
Safety outcomes
No significant difference in adverse events due to pulmonary artery catheters or central venous catheters.
Conclusion
In high-risk adult patients aged ≥ 60 years who were scheduled for urgent or elective major surgery, followed by a stay in the ICU, pulmonary artery catheter was not superior to no pulmonary artery catheter with respect to death in the hospital.
Reference
James Dean Sandham, Russell Douglas Hull, Rollin Frederick Brant et al. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14.
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