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Author Notes:

Correspondence: Richard Beale; Richard.Beale@gstt.nhs.uk

Authors' Contributions: RB, FB, KR, and JJ participated in the conception and design of the registry.

RB, GM, FB, JJ, KG, and DPS contributed to the development and conduct of the principal analyses.

All authors contributed to drafting and critically revising the manuscript and read and approved the final version of the manuscript.

Acknowledgments: We would like to acknowledge the efforts of the investigators, fellows, study coordinators, and nurses who were involved in collecting the data for the PROGRESS registry, without their efforts this study would not have been possible.

We would also like to acknowledge the additional statistical support of and detailed discussions with Dr Douglas Haney (Eli Lilly and Co.) and the efforts and input of the PROGRESS Advisory Board: Dr Richard Beale (St. Mary's Hospital, London, UK), Prof Konrad Reinhart (Friedrich Schiller University, Jena, Germany), Prof Frank M Brunkhorst (Friedrich Schiller University, Jena, Germany), Prof Geoffrey Dobb (Royal Perth Hospital, Perth, Australia), Dr Mitchell Levy (Brown University School of Medicine, Providence, RI, USA), Dr Greg Martin (Emory University, Atlanta, GA, USA), Dr Claudio Martin (London Health Sciences Center, London, Ontario, Canada), Prof Graham Ramsay (West Hertfordshire Health Trust, Hemel Hempstead, UK), Dr Eliezer Silva (Hospital Israelita Albert Einstein, Sao Paulo, Brazil), Dr Benoit Vallet (University Hospital of Lille, Lille, France), and Prof Jean-Louis Vincent (Erasme University Hospital, Brussels, Belgium).

Disclosures: Drs Martin, Reinhart, and Beale have all served as consultants to and participated in Eli Lilly and Co sponsored trials.

Drs Janes and Sundin are employees and stockholders of Eli Lilly and Co.

Ms. Garnett is a contractor for Eli Lilly and Co.

Subject:

Research Funding:

Dr Brunkhorst received research grants from Elli Lilly Deutschland GmbH.

Dr Martin's institution received funding for Dr Martin conducting clinical trials with Eli Lilly and Co.

The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes

Tools:

Journal Title:

Critical Care

Volume:

Volume 13, Number 3

Publisher:

, Pages R103-R103

Type of Work:

Article | Final Publisher PDF

Abstract:

Introduction Since the launch of drotrecogin alfa activated (DrotAA), institutions and individual countries have published data on its use in clinical practice, based on audit or registry data. These studies were limited in size and geographic locale and included patients with greater disease severity and higher mortality than those in clinical trials. The purpose of this study was to compare baseline characteristics and clinical outcomes (using appropriate statistical adjustments) of patients treated or not treated with DrotAA from the international PROGRESS (Promoting Global Research Excellence in Severe Sepsis) cohort study of severe sepsis. Methods PROGRESS was a global, non-interventional, multi-center, prospective, observational study of patients having a diagnosis of severe sepsis treated in intensive care units at a participating institution. All treatment modalities were as per standard of care at the participating institutions. Baseline characteristics and hospital mortality were analyzed and regression techniques used to develop propensity and outcome models adjusted for baseline imbalances between groups. Results Overall, 14,543 patients from 37 countries were enrolled and 12,492 had complete data for analysis. Germany was the highest enrolling country (1,810; 14.5%) and the US had the most DrotAA patients (206, 23.3%); 882 (7%) overall received DrotAA therapy. DrotAA-treated patients were younger (median age 58 vs. 61 years), had greater organ dysfunction (cardiovascular: 90% vs. 74%; respiratory: 90% vs. 81%; renal: 60% vs. 45%; metabolic: 63% versus 42%; 3 or more organ dysfunctions: 84% vs. 67%) and had a higher median APACHE II score (26 vs. 23, all with P < 0.001). Although in-hospital mortality was similar for DrotAA and non-DrotAA-treated patients (49.6% vs. 49.7%, respectively), after adjusting for imbalances, patients receiving DrotAA had a 28% (0.60 to 0.86, 95% Confidence Intervals) reduction in the odds of death and a relative risk reduction of 17% (P = 0.0003). Conclusions In the PROGRESS registry, DrotAA-treated patients were younger, more severely ill, and had fewer co-morbidities than patients not treated with DrotAA. After adjustment for group differences, a significant reduction in the odds of death was observed for patients that received DrotAA compared with those that did not.

Copyright information:

© 2009 Martin et al.; licensee BioMed Central Ltd.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 2.0 Generic License (http://creativecommons.org/licenses/by/2.0/).

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