ARDS Network (NHLBI) studies: successes and challenges in ARDS clinical research

Abstract

To hasten the development of effective therapy for acute respiratory distress syndrome (ARDS), in 1994, the National Heart, Lung, and Blood Institute initiated a clinical network to carry out multicenter clinical trials of ARDS treatments. The ARDS Network is a clinical research network of approximately 42 hospitals, organized into 12 clinical sites. The goal of the Network is to efficiently test promising agents, devices, or management strategies to improve the care of patients with ARDS. Comprehensive information regarding all completed and ongoing ARDSNet clinical trials is available at www.ardsnet.org, but a brief summary is provided in this article.

Figure 1

Lower Tidal Volume / Higher PEEP Reference Card for ARMA and ALVEOLI Studies. (From: http://www.ardsnet.org)

Figure 2

Patient enrollment in the ARDS Network multicenter clinical trials from 1996 through 2005.

Figure 3

Change in body weight over the first seven days of conservative vs. liberal fluid management in ALI patients in FACTT. Differences were statistically different from day 1 through day 7. After seven days, patients in the liberal arm had gained approximately 7 kg while those in the conservative arm were near their baseline weight.

Figure 4

Patients in FACTT who received conservative fluid management had approximately 3 more days alive and free of mechanical ventilation requirement (ventilator free days) during the first 28 days of study.

Figure 5

Whether managed with a central venous catheter or a pulmonary artery catheter, patients receiving conservative fluid management required significantly fewer red cell transfusions. The bars illustrate the percentage of patients who did not require any red cell transfusions during the first seven days of study.

Figure 6

Bars show percentage of patients who never developed hypotension vs. those who developed hypotension during the first 7 days of study in FACTT. There was no difference in the incidence of hypotension whether management was with a PAC or a CVC, nor was there a difference whether managed in the fluid conservative arm vs. the fluid liberal arm.

Figure 7

Vasopressor use in liberal and conservative arms of FACTT. There were no significant differences in vasopressor requirements during the first week of study.