0
ARTICLE |

Why Sepsis Trials Fail

Woody Denham, MD; James G. Norman, MD
JAMA. 1996;276(21):1723. doi:10.1001/jama.1996.03540210031024.
Text Size: A A A
Published online

To the Editor.  —Dr Bone's Commentary concerning the failure of clinical trials evaluating new therapies in the treatment of sepsis was timely and thoughtful.1 However, there are a few points that we would like to address that undoubtedly contributed to these disappointing clinical trials. Sepsis is difficult to diagnose early in its course prior to the development of end-organ dysfunction. In fact, end-organ dysfunction was an entry criterion in each sepsis study cited by Bone. This study design dictates that the major endpoints used to determine efficacy of anti-inflammatory therapy are the resolution of this dysfunction and (primarily) 28-day mortality. The prevention of end-organ failure, which would most likely have an impact on nearly all of the clinical features of sepsis, including survival, morbidity, and cost, is essentially not amenable to investigation using these trial protocols. Since mortality is directly attributable to the incidence and severity of multiple organ

Topics

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

Figures

Tables

References

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Jobs
brightcove.createExperiences();