Pulmonary artery catheters and central venous catheters did not differ for mortality in acute lung injury.

M e t h o d s Design: Randomized controlled 2×2 factorial design trial (Fluid and Catheter Treatment Trial [FACTT]). Allocation: Concealed.* Blinding: Unblinded.* Follow-up period: 60 days. Setting: 36 centers in the United States and 2 in Canada. Patients: 1001 patients ≥ 13 years of age (mean age 50 y, 53% men) who had acute lung injury for ≤ 48 hours; were receiving positive-pressure ventilation by endotracheal tube; and had a ratio of PaO2 to FIO2 < 300, bilateral infiltrates on chest radiography consistent with pulmonary edema, and no evidence of left atrial hypertension. Exclusion criteria included any use of a PAC between injury onset and enrollment; physician refusal; and chronic or terminal conditions that could affect survival, impair weaning, or compromise compliance. Intervention: Patients were allocated, after stratification by hospital and type of fluid therapy (liberal or conservative use), to a PAC (n = 513) or a CVC (n = 488). For each group, catheter measurements were then used to guide management according to an explicit hemodynamic protocol begun within 2 hours of catheter placement. Outcomes: All-cause mortality. Secondary outcomes were ventilator-free days, intensive care unit (ICU)–free days, organ failure–free days, and adverse effects. The study had 90% power to detect a 10% difference in mortality at 60 days. Patient follow-up: 99.9% (intention-to-treat analysis).