drugset / Trial / NCT00000579
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
FactorialTreatment
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.
Timeline
- Start
- 1994-09
- Primary completion
- —
- Completion
- 2004-07
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketoconazole | Small molecule | — | — |
| Subject | Lisofylline | Small molecule | — | — |
| Subject | Methylprednisolone | Other / unclassified | — | — |