« Previous
Next »
Journal of Critical Care
Volume 23, Issue 4
, Pages 493-499
, December 2008
Important issues in the design and reporting of clinical trials in severe sepsis and acute lung injury
References
- . Limitations of clinical trials in acute lung injury and acute respiratory distress syndrome. Curr Opin Crit Care. 2006;12(1):25–31
- Acute Respiratory Distress Syndrome Network. Plasma surfactant protein levels and clinical outcomes in patients with acute lung injury. Thorax. 2003;58(11):983–988
- Significance of von Willebrand factor in septic and nonseptic patients with acute lung injury. Am J Respir Crit Care Med. 2004;170(7):766–772
- . 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;288(3):L426–L431
- 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;33(1):1–6
- Pathogenetic and prognostic significance of altered coagulation and fibrinolysis in acute lung injury/acute respiratory distress syndrome. Crit Care Med. 2007;35(8):1821–1828
- . Acute lung injury and the acute respiratory distress syndrome: challenges in clinical trial design. Clin Chest Med. 2006;27(4):733–754
- The use of a registry database in clinical trial design: assessing the influence of entry criteria on statistical power and number of eligible patients. Int J Med Inform. 2007;76(2-3):176–183
- . Clinical trial design and outcomes in patients with severe sepsis. Shock. 2003;20(4):295–302
- . Mediator modulation therapy of severe sepsis and septic shock: does it work?. Crit Care Med. 2004;32:282–286
- . Lessons for the future; a review of sepsis past and present. Idrugs. 2007;10(4):264–269
- . The use of immunocompromised animals as models for human septic shock. Shock. 2006;24(Suppl 1):64–71
- International Sepsis Trial (INTERSEPT): Role and impact of a Clinical Evaluation Committee. Crit Care Med. 1996;24(9):1441–1447
- Lemierre's syndrome and genetic polymorphisms: a case report. BMC Infect Dis. 2006;6:115
- Impact of critical care physician staffing on patients with septic shock in a university hospital medical intensive care unit. JAMA. 1988;260(23):3446
- A multicenter, randomized, controlled clinical trial of transfusion in critical care. N Engl J Med. 1999;340:409
- Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345:1368–1377
- . Meta-analysis of randomized controlled trials of selective decontamination of the digestive tract. BMJ. 1993;307:525–532
- . The role of selective digestive tract decontamination on mortality and respiratory tract infections. A meta-analysis. Chest. 1994;105:1101–1108
- Stress ulcer prophylaxis in critically ill patients: resolving discordant meta-analyses. JAMA. 1996;275:308–314
- Bleeding and pneumonia in intensive care patients given ranitidine and sucralfate for prevention of stress ulcer: meta-analysis of randomised controlled trials. BMJ. 2000;321:1–7
- www.brainyquote./quotes/quotes/;./johntukey205950.html.
- The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003;348:1546–1554
- . Epidemiology of acute lung injury and ARDS. Chest. 1999;116:74S
- Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomized controlled trial. Lancet. 2007;369:836–843
- Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001;344:699–709
- Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med. 2005;353:1332–1341
- . Evaluation of medicines for human use. www.emea.europa.eu/pdfs/human/press/pr/8509607en.pdfDecember 18, 2007
- Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005;293:470–476
- . 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;342:1301–1308
- Considerations in the rational design and conduct of phase I/II pediatric clinical trials: avoiding the problems and pitfalls. Clin Pharmacol Ther. 2007;81(4):483–494
- www.eortc.be/.
- . Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005;(7494):330:753;[electronic publication Jan 28 2005 doi:10.1136/bmj.38356.424606.8F (accessed 03 May 2005)]
- Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Ann Intern Med. 2005;143:146–148
- . Randomized, controlled clinical trials in sepsis: has methodological quality improved over time?. Crit Care Med. 2002;30:461–472
- . Ethics and research in critical care. Intensive Care Med. 2006;32(11):1697–1705
- . Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ. 2002;325:249–252
- . Collaborating with industry-choices for the academic medical center. N Engl J Med. 2002;347:1371–1375
- . Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289(4):454–465
☆ Manuscript based partly on presentations from the 3rd Annual International Sepsis Forum Scientific Colloquium in Mougins France, June 2005. Co-Chairs: R. Phillip Dellinger, MD, Konrad Reinhart, MD. Faculty: Edward Abraham, MD, Sean Berenholtz, MD, Christian Brun-Buisson, MD, Thierry Calandra, MD, Terry Clemmer, MD, Jean-Francois Dhainaut, MD, Didier Dreyfuss, MD, Francois Lemaire, MD, John Marshall, MD, Francoise Meunier, MD, Steven Opal, MD, Adrienne Randolph, MD, William Richardson, MD, Thomas Smith, MD, Tom van der Poll, MD, Jean-Louis Vincent, MD.
PII: S0883-9441(08)00029-4
doi: 10.1016/j.jcrc.2007.12.022
© 2008 Elsevier Inc. All rights reserved.
« Previous
Next »
Journal of Critical Care
Volume 23, Issue 4
, Pages 493-499
, December 2008
