Clinical trial design and outcomes in patients with severe sepsis

SM Opal - Shock, 2003 - journals.lww.com
… will be discussed in detail to help define a model for further clinical trials on severe sepsis. …
in the design of severe sepsis trials and review several unsuccessful sepsis trials. Additionally…

Clinical trials for severe sepsis: past failures, and future hopes

SM Opal, AS Cross - Infectious disease clinics of North America, 1999 - Elsevier
… pathophysiology of sepsis, … clinical practice in the management of septic patients. Some
lessons from the past and insights into future needs for improved clinical trial design for sepsis

Management of severe sepsis: advances, challenges, and current status

I Martin-Loeches, MM Levy, A Artigas - Drug design, development …, 2015 - Taylor & Francis
… ) and the results of clinical trials showing immune and hemodynamic benefits, … of severe
sepsis. From the 1950s to the 1980s, high-dose steroids were used in the management of sepsis

The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?

SM Opal, RP Dellinger, JL Vincent, H Masur… - Critical care …, 2014 - journals.lww.com
… unmet medical need in clinical trial design in sepsis studies. The use of … severe sepsis (PROWESS)
study group. Efficacy and safety of recombinant activated protein C for severe sepsis

Important issues in the design and reporting of clinical trials in severe sepsis and acute lung injury

RP Dellinger, JL Vincent, J Marshall, K Reinhart - Journal of critical care, 2008 - Elsevier
… for trial design. Most of our current approach to clinical trial design and reporting in severe
sepsis and acute lung … from previous trials. This manuscript discusses criteria for proceeding to …

Toward smarter lumping and smarter splitting: rethinking strategies for sepsis and acute respiratory distress syndrome clinical trial design

HC Prescott, CS Calfee, BT Thompson… - American journal of …, 2016 - atsjournals.org
… identifying effective therapies in clinical trials is that subgroups of patients at different likelihood
of benefit from disease-modifying therapy (eg, those with mild vs. severe sepsis) end up …

A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock

…, Methylprednisolone Severe Sepsis Study … - … England Journal of …, 1987 - Mass Medical Soc
… Our study was designed as a prospective, randomized, double-blind, … this study and previous
clinical trials, we defined criteria for the presumptive diagnosis of severe sepsis and septic

Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial

G Bertolini, G Iapichino, D Radrizzani, R Facchini… - Intensive care …, 2003 - Springer
… At the end of 1998 we designed a study to compare two opposite approaches in providing
nutritional support to critical patient. The first approach (PN) gives the maximum priority to …

High-dose antithrombin III in severe sepsis: a randomized controlled trial

…, RC Bone, SM Opal, KyberSept Trial Study Group… - Jama, 2001 - jamanetwork.com
… of a separate article with a detailed analysis of similarities and differences between antithrombin
III and recombinant human activated protein C and the design of these 2 clinical trials. …

Effect of a machine learning-based severe sepsis prediction algorithm on patient survival and hospital length of stay: a randomised clinical trial

DW Shimabukuro, CW Barton… - BMJ open …, 2017 - bmjopenrespres.bmj.com
… patient outcomes and its design to predict severe sepsis up to 4 hours in advance.11
Predictions made by the MLA in this study likely also influenced the septic shock counts observed …