Sunday, 11 May 2014

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Sender's message: Sepsis or genomics or altitude: JKB_daily1

Sent on Sunday, 2014 May 11
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PubMed Results
Items 1 - 3 of 3

1. N Engl J Med. 2014 May 1;370(18):1673-6. doi: 10.1056/NEJMp1400276. Epub 2014 Apr 16.

Regulatory mandates for sepsis care--reasons for caution.

Rhee C1, Gohil S, Klompas M.

Author information:
1From the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, and the Department of Medicine, Brigham and Women's Hospital - both in Boston (C.R., M.K.); and the Department of Medicine, University of California at Irvine, Irvine (S.G.).

Free Article
PMID: 24738642 [PubMed - indexed for MEDLINE]
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2. N Engl J Med. 2014 May 1;370(18):1750-1. doi: 10.1056/NEJMe1402564. Epub 2014 Mar 18.

The ProCESS trial--a new era of sepsis management.

Lilly CM.

Author information:
From the Division of Pulmonary, Allergy and Critical Care Medicine, University of Massachusetts Medical School, UMass Memorial Medical Center, Worcester.

Comment on

  • A randomized trial of protocol-based care for early septic shock. [N Engl J Med. 2014]
PMID: 24635774 [PubMed - indexed for MEDLINE]
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3. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.

A randomized trial of protocol-based care for early septic shock.

ProCESS Investigators, Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC.

Collaborators: Angus DC, Barnato AE, Eaton TL, Gimbel E, Huang DT, Keener C, Kellum JA, Landis K , Pike F, Stapleton DK, Weissfeld LA, Willochell M, Wofford KA, Yealy DM, Kulstad E, Watts H, Venkat A, Hou PC, Massaro A, Parmar S, Limkakeng AT Jr, Brewer K, Delbridge TR, Mainhart A, Chawla LS, Miner JR, Allen TL, Grissom CK, Swadron S, Conrad SA, Carlson R, LoVecchio F, Bajwa EK, Filbin MR, Parry BA, Ellender TJ, Sama AE, Fine J, Nafeei S, Terndrup T, Wojnar M, Pearl RG, Wilber ST, Sinert R, Orban DJ, Wilson JW, Ufberg JW, Albertson T, Panacek EA, Parekh S, Gunn SR, Rittenberger JS, Wadas RJ, Edwards AR, Kelly M, Wang HE, Holmes TM, McCurdy MT, Weinert C, Harris ES, Self WH, Dubinski D, Phillips CA, Migues RM, Bernard GR, Berry DA, Brock DW, Cnaan A, Fost NC, Lewis RJ, Nathens AB, Rubenfeld GD.

Comment in

Abstract

BACKGROUND:

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary.

METHODS:

In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support.

RESULTS:

We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.

CONCLUSIONS:

In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

PMID: 24635773 [PubMed - indexed for MEDLINE]
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