CLINICAL CENTERS FOR A CLINICAL NETWORK FOR THE TREATMENT OF ADULT RESPIRATORY 
DISTRESS SYNDROME (ARDS) SOL NHLBI-HR-01-01

Release Date:  March 6, 2000

NOTICE:  HL-00-004

National Heart, Lung and Blood Institute

The National Heart, Lung and Blood Institute (NHLBI) 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 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 continental 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.  The RFP will 
be available at http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp.  All 
questions relating to this RFP shall be directed to Ms. Pamela S. Lew at 
301/435-0340 or [email protected].

NIH, NATIONAL HEART, LUNG AND BLOOD INSTITUTE, COB, HLVD Contracts 
Section, 6701 Rockledge Drive, Room 6104, Bethesda, MD 20892-7902

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