N Engl J Med. 2006 May 25;354(21):2213-24. Epub 2006 May 21.
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome
(ARDS) Clinical Trials Network, Wheeler AP, Bernard GR, Thompson BT, Schoenfeld
D, Wiedemann HP, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL.
Vanderbilt University, Nashville, USA. art.wheeler@vanderbilt.edu
BACKGROUND: The balance between the benefits and the risks of pulmonary-artery
catheters (PACs) has not been established. METHODS: We evaluated the relationship
of benefits and risks of PACs in 1000 patients with established acute lung injury
in a randomized trial comparing hemodynamic management guided by a PAC with
hemodynamic management guided by a central venous catheter (CVC) using an
explicit management protocol. Mortality during the first 60 days before discharge
home was the primary outcome. RESULTS: The groups had similar baseline
characteristics. The rates of death during the first 60 days before discharge
home were similar in the PAC and CVC groups (27.4 percent and 26.3 percent,
respectively; P=0.69; absolute difference, 1.1 percent; 95 percent confidence
interval, -4.4 to 6.6 percent), as were the mean (+/-SE) numbers of both
ventilator-free days (13.2+/-0.5 and 13.5+/-0.5; P=0.58) and days not spent in
the intensive care unit (12.0+/-0.4 and 12.5+/-0.5; P=0.40) to day 28. PAC-guided
therapy did not improve these measures for patients in shock at the time of
enrollment. There were no significant differences between groups in lung or
kidney function, rates of hypotension, ventilator settings, or use of dialysis or
vasopressors. Approximately 90 percent of protocol instructions were followed in
both groups, with a 1 percent rate of crossover from CVC- to PAC-guided therapy.
Fluid balance was similar in the two groups, as was the proportion of
instructions given for fluid and diuretics. Dobutamine use was uncommon. The PAC
group had approximately twice as many catheter-related complications
(predominantly arrhythmias). CONCLUSIONS: PAC-guided therapy did not improve
survival or organ function but was associated with more complications than
CVC-guided therapy. These results, when considered with those of previous
studies, suggest that the PAC should not be routinely used for the management of
acute lung injury. (ClinicalTrials.gov number, NCT00281268.). Copyright 2006
Massachusetts Medical Society.