Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

NCT00000579 | Completed Phase 3

• 35 other identifiers: 217N01 HR16146N01 HR16147N01 HR16148N01 HR16149N01 HR16150N01 HR16151N01 HR16152N01 HR16153N01 HR16154N01 HR16155N01 HR46054N01 HR46055N01 HR46056N01 HR46057N01 HR46058N01 HR46059N01 HR46060N01 HR46061N01 HR46062N01 HR46063N01 HR46064N01HR56165N01HR56166N01HR56167N01HR56168N01HR56169N01HR56170N01HR56171N01HR56172N01HR56173N01HR56174N01HR56175N01HR56176N01HR56179
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 21

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Vary by protocol

Interventions

Low Tidal Volume Ventilation PROCEDURE

Positive End-Expiratory Pressure PROCEDURE

Lysofylline DRUG

Methylprednisolone DRUG

Ketoconazole DRUG

Fluid Management PROCEDURE

Pulmonary Artery Catheter PROCEDURE

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (21)

University of California

San Francisco, California, 94143, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Foundation

Rochester, Minnesota, 55905, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas

San Antonio, Texas, 78229-3900, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84143, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (33)

• 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. doi: 10.1001/jama.283.15.1995.

  PMID: 10789668 BACKGROUND

• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

  PMID: 10793162 BACKGROUND

• 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. doi: 10.1016/s0272-5231(05)70161-1.

  PMID: 11019722 BACKGROUND

• 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. doi: 10.1097/00003246-200102000-00002.

  PMID: 11246299 BACKGROUND

• Eisner MD, Thompson T, Hudson LD, Luce JM, Hayden D, Schoenfeld D, Matthay MA; Acute Respiratory Distress Syndrome Network. 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. doi: 10.1164/ajrccm.164.2.2011093.

  PMID: 11463593 BACKGROUND

• 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. doi: 10.1378/chest.120.5.1622.

  PMID: 11713144 BACKGROUND

• 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.

  PMID: 11777361 BACKGROUND

• 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. doi: 10.1097/00003246-200201000-00001.

  PMID: 11902249 BACKGROUND

• 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.

  PMID: 11572755 BACKGROUND

• Schoenfeld DA, Bernard GR; ARDS Network. 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. doi: 10.1097/00003246-200208000-00016.

  PMID: 12163791 BACKGROUND

• Eisner MD, Thompson BT, Schoenfeld D, Anzueto A, Matthay MA; Acute Respiratory Distress Syndrome Network. 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. doi: 10.1164/ajrccm.165.7.2109059.

  PMID: 11934725 BACKGROUND

• 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.

  PMID: 11878247 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000063475.65751.1D.

  PMID: 12794394 BACKGROUND

• Brower RG, Ware LB, Berthiaume Y, Matthay MA. Treatment of ARDS. Chest. 2001 Oct;120(4):1347-67. doi: 10.1378/chest.120.4.1347.

  PMID: 11591581 BACKGROUND

• 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. doi: 10.1097/00003246-200207000-00039.

  PMID: 12130991 BACKGROUND

• Morris AH. Rational use of computerized protocols in the intensive care unit. Crit Care. 2001 Oct;5(5):249-54. doi: 10.1186/cc1041. Epub 2001 Sep 13.

  PMID: 11737899 BACKGROUND

• 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. doi: 10.7326/0003-4819-140-5-200403020-00009.

  PMID: 14996675 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000090001.91640.45.

  PMID: 14605529 BACKGROUND

• 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. doi: 10.1136/thorax.58.11.983.

  PMID: 14586055 BACKGROUND

• Ware LB, Eisner MD, Thompson BT, Parsons PE, Matthay MA. Significance of von Willebrand factor in septic and nonseptic patients with acute lung injury. Am J Respir Crit Care Med. 2004 Oct 1;170(7):766-72. doi: 10.1164/rccm.200310-1434OC. Epub 2004 Jun 16.

  PMID: 15201135 BACKGROUND

• Levy MM. PEEP in ARDS--how much is enough? N Engl J Med. 2004 Jul 22;351(4):389-91. doi: 10.1056/NEJMe048103. No abstract available.

  PMID: 15269320 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000127266.39560.96.

  PMID: 15187508 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000149854.61192.dc.

  PMID: 15644641 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000150650.70142.e9.

  PMID: 15644654 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000149836.76063.71.

  PMID: 15644650 BACKGROUND

• 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. doi: 10.1056/NEJMoa032193.

  PMID: 15269312 BACKGROUND

• 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. doi: 10.1164/ajrccm.170.2.958. No abstract available.

  PMID: 15242856 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000155782.86244.42.

  PMID: 15753743 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000159201.08203.10.

  PMID: 15818118 BACKGROUND

• 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. doi: 10.1152/ajplung.00302.2004. Epub 2004 Oct 29.

  PMID: 15516488 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000157786.41506.24.

  PMID: 15818103 BACKGROUND

• Hager DN, Krishnan JA, Hayden DL, Brower RG; ARDS Clinical Trials Network. Tidal volume reduction in patients with acute lung injury when plateau pressures are not high. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1241-5. doi: 10.1164/rccm.200501-048CP. Epub 2005 Aug 4.

  PMID: 16081547 BACKGROUND

• 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. doi: 10.1097/CCM.0B013E3181653895.

  PMID: 18401254 DERIVED

Related Links

• Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

MeSH Terms

Conditions

Respiratory Distress Syndrome; Lung Diseases

Interventions

Positive-Pressure Respiration; Methylprednisolone; Ketoconazole

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Edward Abraham, MD

  University of Colorado, Denver

  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 Health Sciences Center in New Orleans

  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 Health Sciences

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1994
• Study Completion: July 1, 2004
• Last Updated: March 23, 2016

Record last verified: 2006-08

Locations

US (20); CA (1)