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PDF Data Dictionary (PDF - 478.5 KB)
PDF CRFs (PDF - 773.4 KB)
PDF Protocol (PDF - 2.0 MB)

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Acute Respiratory Distress Network Study 05 (ARDSNet 05) Fluid and Catheter Treatment Trial (FACTT)

Website: http://www.ardsnet.org/
Clinical Trials URL: http://clinicaltrials.gov/ct2/show/...
Study Type: Clinical Trial
Prepared on October 13, 2008
Last Updated on August 24, 2006
Study Dates: 2000-2005
Consent: Restricted Consent
Consent Restrictions: Consent is tiered regarding genetic research.
Commercial Use Restrictions: No
NHLBI Division: DLD
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information

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.

Subjects

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.

Conclusions

Although there was no significant difference in the primary outcome of 60-day mortality, the conservative strategy of fluid management was associated with improved lung function and shortened the duration of mechanical ventilation and intensive care without increasing nonpulmonary-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)