Anest. intenziv. Med. 2017;28(3):168-175

Practical application of the results of clinical trialsIntesive Care Medicine - Special Article

P. Sklienka1,2,*, J. ®vaka1, R. Kula1,2
1 Klinika anesteziologie, resuscitace a intenzivní medicíny, Fakultní nemocnice Ostrava
2 Katedra intenzivní medicíny, urgentní medicíny a forenzních oborů, Lékařská fakulta, Ostravská univerzita

Intensive Care Medicine is a field in which the outcome depends on many factors. Clinical trials are required to assess the impact of various interventions on outcome. They form the fundamentals of evidence-based medicine but knowing their limitations is necessary for their proper application in clinical practice. Personalized medicine is defined as clinical management based on evidence-based medicine individually tailored to each patient and their response to previous interventions.

Keywords: clinical trials; evidence based medicine; personalized medicine

Received: January 19, 2017; Accepted: February 3, 2017; Published: June 1, 2017  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Sklienka P, ®vaka J, Kula R. Practical application of the results of clinical trials. Anest. intenziv. Med. 2017;28(3):168-175.
Download citation

References

  1. Milbrandt EB, Kersten A, Rahim MT, et al. Growth of intensive care unit resource use and its estimated cost in Medicare. Crit Care Med 2008;36:2504-2510. Go to original source... Go to PubMed...
  2. Vincent JL, Marshall JC, Namendys-Silva SA, et al. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med 2014;2:380-386. Go to original source... Go to PubMed...
  3. Vincent JL, Hall JB, Slutsky AS. Ten big mistakes in intensive care medicine. Intensive Care Med 2015;41:505-507. Go to original source... Go to PubMed...
  4. Delaney AP, Dan A, McCaffrey J, et al. The role of albumin as a resuscitation fluid for patients with sepsis: a systematic review and meta-analysis. Crit Care Med 2011;39:386-391. Go to original source... Go to PubMed...
  5. Xu JY, Chen QH, Xie JF, et al. Comparison of the effects of albumin and crystalloid on mortality in adult patients with severe sepsis and septic shock: a meta-analysis of randomized clinical trials. Crit Care 2014;18:702. Go to original source... Go to PubMed...
  6. Jiang L, Jiang S, Zhang M, et al. Albumin versus other fluids for fluid resuscitation in patients with sepsis: a meta-analysis. nPLoS One 2014;9:e114666. Go to original source... Go to PubMed...
  7. Patel A, Laffan MA, Waheed U, et al. Randomised trials of human albumin for adults with sepsis: systematic review and meta-analysis with trial sequential analysis of all-cause mortality. BMJ 2014;349:g4561. Go to original source... Go to PubMed...
  8. Moreno R, Rhodes A. Evidence should not be viewed in isolation. Crit Care Med 2010;38:S528-33. Go to original source... Go to PubMed...
  9. McAuley DF, O'kane C, Griffiths MJ. A stepwise approach to justify phase III randomized clinical trials and enhance the likelihood of a positive result. Crit Care Med 2010;38:S523-527. Go to original source... Go to PubMed...
  10. Gattinoni L, Tonetti T, Quintel M. Improved survival in critically ill patients: are large RCTs more useful than personalized medicine? We are not sure. Intensive Care Med 2016;42:1781-1783. Go to original source... Go to PubMed...
  11. Vincent JL. We should abandon randomized controlled trials in the intensive care unit. Crit Care Med 2010;38:S534-538. Go to original source... Go to PubMed...
  12. Vincent JL, Creteur J. Paradigm shifts in critical care medicine: the progress we have made. Crit Care 2015;19:S10. Go to original source... Go to PubMed...
  13. Vincent JL. Give your patient a fast hug (at least) once a day. Crit Care Med 2005;33:1225-1229. Go to original source... Go to PubMed...
  14. Vincent JL, Bernard GR, Beale R, et al. Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: further evidence for survival and safety and implications for early treatment. Crit Care Med 2005;33:2266-2277. Go to original source... Go to PubMed...
  15. Perner A, Haase N, Guttormsen AB, et al. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med 2012;367:124-134. Go to original source... Go to PubMed...
  16. Hjortrup PB, Haase N, Wetterslev J, et al. Gone fishing in a fluid trial. Crit Care Resusc 2016;18:55-58. Go to original source... Go to PubMed...
  17. Ridgeon EE, Young PJ, Bellomo R, et al. The Fragility Index in Multicenter Randomized Controlled Critical Care Trials. Crit Care Med 2016;44:1278-1284. Go to original source... Go to PubMed...
  18. Marik PE. Evidence-Based Critical Care. Spinger 2015. Go to original source...
  19. Macias WL, Vallet B, Bernard GR, et al. Sources of variability on the estimate of treatment effect in the PROWESS trial: implications for the design and conduct of future studies in severe sepsis. Crit Care Med 2004;32:2385-2391. Go to original source... Go to PubMed...
  20. Perner A, Myburgh J. Ten 'short-lived' beliefs in intensive care medicine. Intensive Care Med 2015;41:1703-1706. Go to original source... Go to PubMed...
  21. Afshari A, Brok J, Møller AM, et al. Inhaled nitric oxide for acute respiratory distress syndrome (ARDS) and acute lung injury in children and adults. Cochrane Database Syst Rev 2010; Jul 7. Go to original source... Go to PubMed...
  22. Marhong JD, Munshi L, Detsky M, et al. Mechanical ventilation during extracorporeal life support (ECLS): a systematic review. Intensive Care Med 2015;41:994-1003. Go to original source... Go to PubMed...
  23. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345:1368-1377. Go to original source... Go to PubMed...
  24. Peake SL, Delaney A, Bailey M, et al. Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014;371:1496-1506. Go to original source... Go to PubMed...
  25. Mouncey PR, Osborn TM, Power GS, et al. Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock. Health Technol Assess 2015; 19:i-xxv,1-150. Go to original source... Go to PubMed...
  26. Yealy DM, Kellum JA, Huang DT, et al. A randomized trial of protocol-based care for early septic shock. ProCESS Investigators. N Engl J Med 2014;370:1683-1693. Go to original source...
  27. Pisano A, Landoni G, Lomivorotov V, et al. Worldwide Opinion on Multicenter Randomized Interventions Showing Mortality Reduction in Critically Ill Patients: A Democracy-Based Medicine Approach. J Cardiothorac Vasc Anesth 2016;30:1386-1395. Go to original source... Go to PubMed...
  28. Sprung CL, Annane D, Keh D, et al. N Engl J Med. Hydrocortisone therapy for patients with septic shock 2008;358:111-124. Go to original source...
  29. Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008;358:125-139. Go to original source...
  30. Finfer S, Bellomo R, Boyce N, et al. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004;350:2247-2256. Go to original source... Go to PubMed...
  31. Pettilä V, Hjortrup PB, Jakob SM, et al. Control groups in recent septic shock trials: a systematic review. Intensive Care Med 2016;42:1912-1921. Go to original source... Go to PubMed...
  32. Ospina-Tascón GA, Büchele GL, Vincent JL. Multicenter, randomized, controlled trials evaluating mortality in intensive care: doomed to fail? Crit Care Med 2008;36:1311-1322. Go to original source... Go to PubMed...
  33. Singer M. Advancing critical care: time to kiss the right frog. Crit Care 2013;17 Suppl 1:S3. Go to original source... Go to PubMed...




Anesteziologie a intenzivní medicína

Madam, Sir,
please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

I declare:

  1. that I have met the above instruction
  2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited


No

Yes

If your statement is not true, please be aware
that brings the risk of danger to their health or the health of others.