1. 2017 - Pooled RCTs: Early goal-directed therapy does not reduce mortality more than usual care in early septic shock.
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Fuller, Brian M. and Carpenter, Christopher R.
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MEDICAL protocols , *MORTALITY , *SEPTIC shock , *TREATMENT effectiveness - Abstract
Question In patients who present to the emergency department with septic shock, does early goal-directed therapy (EGDT) reduce mortality more than usual care? Scope Included studies compared EGDT with usual care in patients who presented to the emergency department with septic shock. Outcomes included mortality at 90 days (primary) and 28 days, and hospital discharge. ClinicalTrials.gov NCT02030158. Methods The Protocolized Resuscitation in Sepsis Meta-Analysis (PRISM) study was an individual patient data meta-analysis of 3763 patients (median age 65 y, 58% men) from 3 randomized controlled trials (RCTs): Protocolized Care for Early Septic Shock (ProCESS), Australian Resuscitation in Sepsis Evaluation (ARISE), and Protocolised Management in Sepsis (ProMISe). This meta-analysis was planned before patients were entered into any of the 3 RCTs. Patients from the protocol- based standard therapy group of the ProCESS trial were excluded. Data were analyzed using an intention-to-treat approach. Main results EGDT did not differ from usual care for mortality at 90 or 28 days or at hospital discharge (Table). In prespecified subgroup analyses, the effect of EGDT on 90-day mortality did not differ by age, sex, refractory hypotension and/or hyperlactatemia, baseline lactate level, customized prediction of risk for death, or hospital propensity to use vasopressors or fluids during resuscitation (P ≥0.09). Conclusion In patients with septic shock, early goal-directed therapy does not reduce mortality. Sources of funding: Supported in part by the U.S. National Institute of General Medical Sciences, National Institutes of Health (ProCESS trial); National Health and Medical Research Council of Australia, the Intensive Care Foundation, and the Alfred Foundation (ARISE trial); United Kingdom National Institute for Health Research Health Technology Assessment Programme (ProMISe trial). [ABSTRACT FROM AUTHOR]
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- 2017
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