National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

A -- CLINICAL CENTERS FOR A CLINICAL NETWORK FOR THE TREATMENT OF ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) SOL NHLBI-HR-01-01 DUE 051200 POC Pamela S. Lew, 301/435-0340, lewp@nhlbi.nih.gov WEB: RFP NHLBI-HR-01-01, Clinical Centers for a Clinical, http://www.nhlbi.nih.gov/funding/inits/index.htm. E-MAIL: lewp@nhlbi.nih.gov, lewp@nhlbi.nih.gov. The National Heart, Lung and Blood Institute will support a program to establish ten (10) additional Critical Care Treatment Groups (CCTG) to participate in an ongoing study being conducted by the NHLBI- sponsored Acute Respiratory Distress Syndrome Clinical Trials network (ARDSnet). The ARDSnet is a group of 10 CCTGs and a Clinical Coordinating Center (CCC) that has been in existence since 1994. The Network tests new therapies and validates current therapies to treat ARDS and acute lung injury (ALI). The new CCTGs will participate in a prospective randomized protocol that has been developed by the ARDSnet Steering Committee to test the efficacy and safety of the pulmonary artery catheter (PAC) in the treatment of ARDS. A two-by-two factorial design will be used to compare the PAC with a central venous catheter in managing a conservative or liberal fluid strategy in patients with ARDS. The primary endpoint will be mortality and secondary endpoints will be ventilator free days and organ failure. The investigators will be responsible for 1) participating in the oversight of the PAC protocol with the other CCTGs; 2) training staff to conduct the study as outlined in the protocol and manual of operations; 3) enrolling and treating 30 patients per year (13 years of age or older with a gender and racial composition representative of the local population) with ARDS or ALI; 4) performing follow-up assessment on the subjects in the manner specified in the protocol and manual of operations; 5) collecting and forwarding subject data to the CCC; 6) interacting with the CCC to provide data and information necessary for data analysis; 7) participating with other study investigators in the preparation and writing of reports and manuscripts for publication. This is not a request for proposals. It should be noted that award of a contract for this study shall be made only to offerors who are located in the continential United States and Canada. It is anticipated that RFP NHLBI-HR-01-01 will be available on or about March 10, 2000 with proposals due on May 12, 2000. Posted 02/28/00 (W-SN429074). (0059)

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