Wheeler AP, Bernard GR, Thompson BT, Schoenfeld D, Wiedemann HP, deBoisblanc B, Connors AF, Jr., Hite RD, Harabin AL. Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury. N Engl J Med 2006;354:2213–2224 .
The balance between the benefits and the risks of pulmonary artery catheters (PACs) has not been established.
To assess the safety and efficacy of PAC-guided vs. central venous catheter-guided management in reducing mortality and morbidity in patients with established acute lung injury (ALI).
Randomized, controlled, non-blinded trial.
36 centers in the United States and 2 in Canada.
1000 patients with established acute lung injury of less than 48 hours duration. Subjects were excluded if they already had a PAC in place or had chronic conditions that could independently influence survival, impair weaning, or compromise compliance with the protocol, such as dialysis dependence, severe lung or neuromuscular disease, or terminal illness.
Subjects were randomized to hemodynamic management guided by a PAC or a CVC using an explicit management protocol.
Hospital mortality during the first 60 days before discharge home was the primary outcome. Secondary outcomes included ventilator-free days, intensive care unit-free days, organ failure-free days, and adverse events.
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 subgroup of 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), though rates per catheter insertion were similar between groups.
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.).