In a separate but interrelated component of FACTT, investigators evaluated the safety and efficacy of a PAC compared to a CVC to guide management of patients with ALI and ARDS. Both types of catheters are used to deliver fluids to the patient and to assess heart and lung function by measuring pressures in specific blood vessels. With a CVC, a short tube is placed in a large vein. A PAC provides additional information on heart and lung function, such as the pressures in the lung and cardiac output, because the catheter passes through the heart and into a large artery in the lung. Because the PAC is more invasive, concerns had been raised about whether increased risks for other complications outweigh the benefits of the device.

In FACTT, PAC-guided therapy did not improve survival or organ function compared to CVC. After 28 days in the study, the numbers of ventilator-free days and ICU-free days also were similar between the two groups. However, participants in the PAC group had twice as many complications related to catheters compared to those in the CVC group.


"The PAC did not provide any additional benefit over CVC to patients with acute lung injury," noted Arthur P. Wheeler, MD, Associate Professor of Medicine, Vanderbilt University Medical Center, and lead author of the FACTT catheter study. "Patients managed with pulmonary-artery catheters are more likely to have complications such as disturbances in their heart rhythms, so we do not recommend routine use of PACs to manage patients with acute lung injury."

FACTT investigators also reported that they found no interaction between the type of catheter used and the fluid management strategy.

"The fluid management and catheter treatment study represents another key finding concerning the importance of supportive care for patients with ALI/ARDS," said Andrea Harabin, PhD, NHLBI project officer for the NHLBI ARDS Clinical Research Network. "FACTT was a large randomized clinical trial with a highly defined protocol followed under rigorous monitoring. These results are relevant to ALI patients and clinicians nationwide."

FACTT is one of six clinical trials conducted by the NHLBI ARDS Clinical Research Network, which was formed in 1994 to hasten the development of effective therapies for ALI and ARDS by evaluating new treatments and management practices. The network's first clinical trial, a ventilator management study, was stopped early in 1999 when data showed that death rates were lowered by approximately 25 percent among patients receiving small breaths of air from the mechanical ventilator compared to patients receiving large breaths of air, which were the standard of care at that time. The results have been heralded as signaling a new era of research and management of the critically ill. Recently published results from another ARDS Network study showed that corticosteroids do not improve survival and may increase complications in patients with late-stage ARDS.

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