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Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
This study has been completed.
First Received: October 27, 1999   Last Updated: August 24, 2006   History of Changes
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000579
  Purpose

The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.


Condition Intervention Phase
Respiratory Distress Syndrome, Adult
Lung Diseases
 Procedure: Low Tidal Volume Ventilation
Procedure: Positive End-Expiratory Pressure
Drug: Lysofylline
Drug: Methylprednisolone
Drug: Ketoconazole
Procedure: Fluid Management
Procedure: Pulmonary Artery Catheter
 Phase III

Study Type: Interventional
Study Design: Treatment, Placebo Control, Factorial Assignment
Official Title: Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest Methylprednisolone
U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Vary by protocol

Study Start Date: September 1994
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women
  • 13 years of age or older
  • ARDS or risk factors for ARDS (patients will be considered at risk if they are critically ill and have trauma, sepsis, shock, pneumonia, inhalation injury, drug overdose, pancreatitis, or hypertransfusion)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000579

  Hide Study Locations
Locations
United States, California
University of California
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Louisiana State University
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Foundation
Rochester, Minnesota, United States, 55905
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Duke University
Durham, North Carolina, United States, 27708
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas
San Antonio, Texas, United States, 78229-3900
United States, Utah
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Edward Abraham, MD University of Colorado at Denver and Health Sciences Center
Principal Investigator: Antonio Anzueto, MD University of Texas
Principal Investigator: Roy Brower, MD Johns Hopkins University
Principal Investigator: Alfred F. Connors, MD University of Virginia
Principal Investigator: Bennett P. deBoisblanc, MD Louisiana State University
Principal Investigator: Bennett P. deBoisblanc, MD Louisiana State University Health Science Center
Principal Investigator: Michael Donahoe, MD University of Pittsburgh
Principal Investigator: Kalpalatha K. Guntupalli, MD Baylor College of Medicine
Principal Investigator: Robert D. Hite, MD Wake Forest University
Principal Investigator: Robert D. Hite, MD Wake Forest University
Principal Investigator: Rolf Hubmayr, MD Mayo Clinic
Principal Investigator: Neil MacIntyre, MD Duke University
Principal Investigator: Michael A. Matthay, MD University of California, San Francisco
Principal Investigator: Alan Morris, MD Latter Day Saints Hospital
Principal Investigator: Michael J. Murray Mayo Foundation
Principal Investigator: James A. Russell, MD University of British Columbia
Principal Investigator: Gregory A. Schmidt, MD, FCCP University of Chicago
Principal Investigator: David A. Schoenfeld, PhD Massachusetts General Hospital
Principal Investigator: Jay S. Steingrub, MD, FCCP Baystate Medical Center
Principal Investigator: Arthur Wheeler, MD Vanderbilt University
Principal Investigator: Herbert Wiedemann, MD Cleveland Clinic Lerner College of Medicine
  More Information

Additional Information:
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)  This link exits the ClinicalTrials.gov site

Publications:
[No authors listed] Ketoconazole for early treatment of acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. The ARDS Network. JAMA. 2000 Apr 19;283(15):1995-2002. Erratum in: JAMA 2000 Nov 15;284(19):2450. JAMA 2001 Oct 3;286(13):1578. JAMA 2200 Nov 22-29;284(20):2597.
[No authors listed] Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000 May 4;342(18):1301-8.
Brower RG, Fessler HE. Mechanical ventilation in acute lung injury and acute respiratory distress syndrome. Clin Chest Med. 2000 Sep;21(3):491-510, viii. Review.
Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med. 2001 Feb;29(2):235-41.
Eisner MD, Thompson T, Hudson LD, Luce JM, Hayden D, Schoenfeld D, Matthay MA. Efficacy of low tidal volume ventilation in patients with different clinical risk factors for acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 Jul 15;164(2):231-6.
Thompson BT, Hayden D, Matthay MA, Brower R, Parsons PE. Clinicians' approaches to mechanical ventilation in acute lung injury and ARDS. Chest. 2001 Nov;120(5):1622-7.
Ely EW, Wheeler AP, Thompson BT, Ancukiewicz M, Steinberg KP, Bernard GR. Recovery rate and prognosis in older persons who develop acute lung injury and the acute respiratory distress syndrome. Ann Intern Med. 2002 Jan 1;136(1):25-36.
[No authors listed] Randomized, placebo-controlled trial of lisofylline for early treatment of acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2002 Jan;30(1):1-6.
Kallet RH, Corral W, Silverman HJ, Luce JM. Implementation of a low tidal volume ventilation protocol for patients with acute lung injury or acute respiratory distress syndrome. Respir Care. 2001 Oct;46(10):1024-37. Review.
Schoenfeld DA, Bernard GR. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002 Aug;30(8):1772-7.
Eisner MD, Thompson BT, Schoenfeld D, Anzueto A, Matthay MA. Airway pressures and early barotrauma in patients with acute lung injury and acute respiratory distress syndrome. Am J Respir Crit Care Med. 2002 Apr 1;165(7):978-82.
Kallet RH, Luce JM. Detection of patient-ventilator asynchrony during low tidal volume ventilation, using ventilator waveform graphics. Respir Care. 2002 Feb;47(2):183-5. No abstract available.
Goss CH, Brower RG, Hudson LD, Rubenfeld GD; ARDS Network. Incidence of acute lung injury in the United States. Crit Care Med. 2003 Jun;31(6):1607-11.
Brower RG, Ware LB, Berthiaume Y, Matthay MA. Treatment of ARDS. Chest. 2001 Oct; 120(4): 1347-67. Review.
Cook D, Brower R, Cooper J, Brochard L, Vincent JL. Multicenter clinical research in adult critical care. Crit Care Med. 2002 Jul; 30(7): 1636-43.
Morris AH. Rational use of computerized protocols in the intensive care unit. Crit Care. 2001 Oct; 5(5): 249-54. Epub 2001 Sep 13. Review.
O'Brien JM Jr, Welsh CH, Fish RH, Ancukiewicz M, Kramer AM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Excess body weight is not independently associated with outcome in mechanically ventilated patients with acute lung injury. Ann Intern Med. 2004 Mar 2;140(5):338-45.
Brower RG, Morris A, MacIntyre N, Matthay MA, Hayden D, Thompson T, Clemmer T, Lanken PN, Schoenfeld D; ARDS Clinical Trials Network, National Heart, Lung, and Blood Institute, National Institutes of Health. Effects of recruitment maneuvers in patients with acute lung injury and acute respiratory distress syndrome ventilated with high positive end-expiratory pressure. Crit Care Med. 2003 Nov;31(11):2592-7. Erratum in: Crit Care Med. 2004 Mar;32(3):907.
Eisner MD, Parsons P, Matthay MA, Ware L, Greene K; Acute Respiratory Distress Syndrome Network. Plasma surfactant protein levels and clinical outcomes in patients with acute lung injury. Thorax. 2003 Nov;58(11):983-8.
Ware LB, Eisner MD, Thompson BT, Parsons P, Matthay MA, The Acute Respiratory Distress Syndrome Network. Significance of von Willebrand Factor in Septic and Non-septic Patients with Acute Lung Injury. Am J Respir Crit Care Med. 2004 Jun 16 [Epub ahead of print]
Levy MM. PEEP in ARDS--how much is enough? N Engl J Med. 2004 Jul 22;351(4):389-91. No abstract available.
Rubenfeld GD, Cooper C, Carter G, Thompson BT, Hudson LD. Barriers to providing lung-protective ventilation to patients with acute lung injury. Crit Care Med. 2004 Jun;32(6):1289-93.
Parsons PE, Eisner MD, Thompson BT, Matthay MA, Ancukiewicz M, Bernard GR, Wheeler AP; NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network. Lower tidal volume ventilation and plasma cytokine markers of inflammation in patients with acute lung injury. Crit Care Med. 2005 Jan;33(1):1-6; discussion 230-2.
Rizvi K, Deboisblanc BP, Truwit JD, Dhillon G, Arroliga A, Fuchs BD, Guntupalli KK, Hite D, Hayden D; NIH/NHLBI ARDS Clinical Trials Network. Effect of airway pressure display on interobserver agreement in the assessment of vascular pressures in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2005 Jan;33(1):98-103; discussion 243-4.
Cheng IW, Eisner MD, Thompson BT, Ware LB, Matthay MA; Acute Respiratory Distress Syndrome Network. Acute effects of tidal volume strategy on hemodynamics, fluid balance, and sedation in acute lung injury. Crit Care Med. 2005 Jan;33(1):63-70; discussion 239-40.
Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327-36.
Brower RG, Bernard G, Morris A; NIH/NHLBI ARDS Network. Ethics and standard of care in clinical trials. Am J Respir Crit Care Med. 2004 Jul 15;170(2):198-9; author reply 199. No abstract available.
Hough CL, Kallet RH, Ranieri VM, Rubenfeld GD, Luce JM, Hudson LD. Intrinsic positive end-expiratory pressure in Acute Respiratory Distress Syndrome (ARDS) Network subjects. Crit Care Med. 2005 Mar;33(3):527-32.
Silverman HJ, Luce JM, Lanken PN, Morris AH, Harabin AL, Oldmixon CF, Thompson BT, Bernard GR; NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network (ARDSNet). Recommendations for informed consent forms for critical care clinical trials. Crit Care Med. 2005 Apr;33(4):867-82. Review.
Parsons PE, Matthay MA, Ware LB, Eisner MD; National Heart, Lung, Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Elevated plasma levels of soluble TNF receptors are associated with morbidity and mortality in patients with acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2005 Mar;288(3):L426-31. Epub 2004 Oct 29.
Kahn JM, Andersson L, Karir V, Polissar NL, Neff MJ, Rubenfeld GD. Low tidal volume ventilation does not increase sedation use in patients with acute lung injury. Crit Care Med. 2005 Apr;33(4):766-71.
Hager DN, Krishnan JA, Hayden DL, Brower RG. Tidal Volume Reduction In Patients With Acute Lung Injury When Plateau Pressures Are Not High. Am J Respir Crit Care Med. 2005 Aug 4; [Epub ahead of print]

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Arroliga AC, Thompson BT, Ancukiewicz M, Gonzales JP, Guntupalli KK, Park PK, Wiedemann HP, Anzueto A; Acute Respiratory Distress Syndrome Network. Use of sedatives, opioids, and neuromuscular blocking agents in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2008 Apr;36(4):1083-8.

Study ID Numbers: 217, N01 HR16146, N01 HR16147, N01 HR16148, N01 HR16149, N01 HR16150, N01 HR16151, N01 HR16152, N01 HR16153, N01 HR16154, N01 HR16155, N01 HR46054, N01 HR46055, N01 HR46056, N01 HR46057, N01 HR46058, N01 HR46059, N01 HR46060, N01 HR46061, N01 HR46062, N01 HR46063, N01 HR46064, N01 HR56165, N01 HR56166, N01 HR56167, N01 HR56168, N01 HR56169, N01 HR56170, N01 HR56171, N01 HR56172, N01 HR56173, N01 HR56174, N01 HR56175, N01 HR56176, N01 HR56179
Study First Received: October 27, 1999
Last Updated: August 24, 2006
ClinicalTrials.gov Identifier: NCT00000579     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Antineoplastic Agents
Methylprednisolone
Respiratory Distress Syndrome, Adult
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Antifungal Agents
 Therapeutic Uses
Methylprednisolone Hemisuccinate
Disease
Antineoplastic Agents, Hormonal
Respiration Disorders
Gastrointestinal Agents
Methylprednisolone acetate
Ketoconazole
Glucocorticoids
Protective Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Prednisolone
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009



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