Acute Respiratory Distress Syndrome Clinical Network: Fluid and Catheter Treatment Trial (ARDSNet FACTT-BioLINCC)

Data Access NOTE: Please refer to the “Authorized Access” section below for information about how access to the data from this accession differs from many other dbGaP accessions.Biospecimens: Access to Biospecimens is through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Biospecimens from ARDSNet-FACTT include plasma, DNA, and serum. Please note that use of biospecimens in genetic research is subject to a tiered consent. Objectives: This study evaluated the benefits and risks of Pulmonary Artery Catheters (PACs) in patients with established acute lung injury in a trial comparing hemodynamic management guided by a PAC with hemodynamic management guided by a central venous catheter (CVC) using an explicit management protocol.Background: Optimal fluid management in patients with acute lung injury is unknown. Diuresis or fluid restriction may improve lung function but could jeopardize extrapulmonary organ perfusion.Participants: This randomized study compared a conservative and a liberal strategy of fluid management using explicit protocols applied for seven days in 1000 patients with acute lung injury. The primary end point was death at 60 days. Secondary end points included the number of ventilator-free days and organ-failure-free days and measures of lung physiology. Design: Participants were randomly assigned to a strategy involving either conservative or liberal use of fluids with concealed allocation in permuted blocks of eight with the use of an automated system. Participants were simultaneously and randomly assigned to receive either a pulmonary-artery catheter or a central venous catheter in a two-by-two factorial design.Conclusions: There was no significant difference in the primary outcome of 60-day mortality; however, the conservative strategy of fluid management was associated with improved lung function and shortened the duration of mechanical ventilation and intensive care without increasing non-pulmonary organ failures. These results support the use of a conservative strategy of fluid management in patients with acute lung injury. (NEJM June 15, 2006; Vol 354, No. 24, pp 2564-75; NEJM May 25, 2006; Vol 354, No. 21, pp 2213-24)]]>
Inclusion Criteria:Eligible patients were intubated and received positive-pressure ventilation, had a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 (adjusted if the altitude exceeded 1000 m), and had bilateral infiltrates on chest radiography consistent with the presence of pulmonary edema without evidence of left atrial hypertension. If a potential participant did not have a central venous catheter, the primary physician's intent to insert one was required.Exclusion Criteria:Major reasons for exclusion were the presence of a pulmonary-artery catheter after the onset of acute lung injury; the presence of acute lung injury for more than 48 hours; inability to obtain consent; the presence of chronic conditions that could independently influence survival, impair weaning, or compromise compliance with the protocol (e.g., severe lung or neuromuscular disease or dependence on dialysis); and irreversible conditions for which the estimated six-month mortality rate exceeded 50 percent, such as advanced cancer.]]>