Literature DB >> 22961004

[Enrolment of intensive care patients in clinical studies. Ethical, legal and organizational problems from an interdisciplinary point of view].

A Weimann1, B R Kern, M Löffler, A Sablotzki, F Thiele, F M Brunkhorst.   

Abstract

Nowadays, most patients in hospital die in the intensive care unit from sepsis and multiple organ failure. Clinical research in this critically ill and vulnerable patient population bears a lot of ethical and legal problems; however, it remains a must in order to develop evidence-based diagnostic and therapeutic strategies for life-threatening diseases with special respect to limited health care resources. With regard to the Declaration of Helsinki, good clinical practice guidelines (GCP) from the European Medicines Agency (EMA) and the German medical drug law (AMG) this article discusses ethical and legal aspects of patient inclusion for clinical trials as well as incentives for appropriate patient recruitment from an interdisciplinary point of view.

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Year:  2012        PMID： 22961004     DOI： 10.1007/s00063-012-0153-7

Source DB:  PubMed          Journal:  Med Klin Intensivmed Notfmed        ISSN： 2193-6218            Impact factor:   0.840


  10 in total

1.  Increased mortality associated with growth hormone treatment in critically ill adults.

Authors:  J Takala; E Ruokonen; N R Webster; M S Nielsen; D F Zandstra; G Vundelinckx; C J Hinds
Journal:  N Engl J Med       Date:  1999-09-09       Impact factor: 91.245

Review 2.  [Scientific acquisition of knowledge in operative medicine. The importance of intensive care medicine].

Authors:  F W Schildberg; J N Hoffmann
Journal:  Med Klin Intensivmed Notfmed       Date:  2011-10-07       Impact factor: 0.840

3.  Attitudes and beliefs related to the Canadian critical care nutrition practice guidelines: an international survey of critical care physicians and dietitians.

Authors:  Naomi E Cahill; Sweta Narasimhan; Rupinder Dhaliwal; Daren K Heyland
Journal:  JPEN J Parenter Enteral Nutr       Date:  2010 Nov-Dec       Impact factor: 4.016

Review 4.  A meta-analysis of the association between adherence to drug therapy and mortality.

Authors:  Scot H Simpson; Dean T Eurich; Sumit R Majumdar; Rajdeep S Padwal; Ross T Tsuyuki; Janice Varney; Jeffrey A Johnson
Journal:  BMJ       Date:  2006-06-21

5.  Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.).

Authors:  Stephen A McClave; Robert G Martindale; Vincent W Vanek; Mary McCarthy; Pamela Roberts; Beth Taylor; Juan B Ochoa; Lena Napolitano; Gail Cresci
Journal:  JPEN J Parenter Enteral Nutr       Date:  2009 May-Jun       Impact factor: 4.016

Review 6.  [Ethical and legal aspects of including patients unable to consent in acute therapy studies. Example of a medication study for the treatment of intracerebral hemorrhage--the Heidelberg procedure].

Authors:  T Steiner; I Walter-Sack; J Taupitz; W Hacke; T Strowitzki
Journal:  Dtsch Med Wochenschr       Date:  2008-04       Impact factor: 0.628

7.  Epidemiology of sepsis in Germany: results from a national prospective multicenter study.

Authors:  Christoph Engel; Frank M Brunkhorst; Hans-Georg Bone; Reinhard Brunkhorst; Herwig Gerlach; Stefan Grond; Matthias Gruendling; Guenter Huhle; Ulrich Jaschinski; Stefan John; Konstantin Mayer; Michael Oppert; Derk Olthoff; Michael Quintel; Max Ragaller; Rolf Rossaint; Frank Stuber; Norbert Weiler; Tobias Welte; Holger Bogatsch; Christiane Hartog; Markus Loeffler; Konrad Reinhart
Journal:  Intensive Care Med       Date:  2007-02-24       Impact factor: 17.440

8.  The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study.

Authors:  Cathy Alberda; Leah Gramlich; Naomi Jones; Khursheed Jeejeebhoy; Andrew G Day; Rupinder Dhaliwal; Daren K Heyland
Journal:  Intensive Care Med       Date:  2009-07-02       Impact factor: 17.440

9.  ESPEN Guidelines on Parenteral Nutrition: intensive care.

Authors:  Pierre Singer; Mette M Berger; Greet Van den Berghe; Gianni Biolo; Philip Calder; Alastair Forbes; Richard Griffiths; Georg Kreyman; Xavier Leverve; Claude Pichard
Journal:  Clin Nutr       Date:  2009-06-07       Impact factor: 7.324

10.  Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards.

Authors:  Henry Silverman
Journal:  Ann Intensive Care       Date:  2011-04-13       Impact factor: 6.925
  10 in total
  2 in total

Review 1.  [Immunonutrition in intensive care medicine].

Authors:  A Weimann
Journal:  Med Klin Intensivmed Notfmed       Date:  2013-01-26       Impact factor: 0.840

2.  Acute and long-term dysphagia in critically ill patients with severe sepsis: results of a prospective controlled observational study.

Authors:  Joerg Zielske; Silvia Bohne; Frank M Brunkhorst; Hubertus Axer; Orlando Guntinas-Lichius
Journal:  Eur Arch Otorhinolaryngol       Date:  2014-06-27       Impact factor: 2.503
  2 in total

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