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dc.contributor.authorPRISM Investigators-
dc.contributor.authorRowan, Kathryn M.-
dc.contributor.authorAngus, Derek C.-
dc.contributor.authorBailey, Michael-
dc.contributor.authorBarnato, Amber E.-
dc.contributor.authorBellomo, Rinaldo-
dc.contributor.authorCanter, Ruth R.-
dc.contributor.authorCoats, Timothy J.-
dc.contributor.authorDelaney, Anthony-
dc.contributor.authorGimbel, Elizabeth-
dc.contributor.authorGrieve, Richard D.-
dc.contributor.authorHarrison, David A.-
dc.contributor.authorHiggins, Alisa M.-
dc.contributor.authorHowe, Belinda-
dc.contributor.authorHuang, David T.-
dc.contributor.authorKellum, John A.-
dc.contributor.authorMouncey, Paul R.-
dc.contributor.authorMusic, Edvin-
dc.contributor.authorPeake, Sandra L.-
dc.contributor.authorPike, Francis-
dc.contributor.authorReade, Michael C.-
dc.contributor.authorSadique, M. Zia-
dc.contributor.authorSinger, Mervyn-
dc.contributor.authorYealy, Donald M.-
dc.identifier.citationNew England Journal of Medicine, 376 (23), pp. 2223-2234en
dc.descriptionThe file associated with this record is under embargo until 6 months after publication, in accordance with the publisher's self-archiving policy. The full text may be available through the publisher links provided above.en
dc.description.abstractBACKGROUND: After a single-center trial and observational studies suggesting that early, goal-directed therapy (EGDT) reduced mortality from septic shock, three multicenter trials (ProCESS, ARISE, and ProMISe) showed no benefit. This meta-analysis of individual patient data from the three recent trials was designed prospectively to improve statistical power and explore heterogeneity of treatment effect of EGDT. METHODS: We harmonized entry criteria, intervention protocols, outcomes, resource-use measures, and data collection across the trials and specified all analyses before unblinding. After completion of the trials, we pooled data, excluding the protocol-based standard-therapy group from the ProCESS trial, and resolved residual differences. The primary outcome was 90-day mortality. Secondary outcomes included 1-year survival, organ support, and hospitalization costs. We tested for treatment-by-subgroup interactions for 16 patient characteristics and 6 care-delivery characteristics. RESULTS: We studied 3723 patients at 138 hospitals in seven countries. Mortality at 90 days was similar for EGDT (462 of 1852 patients [24.9%]) and usual care (475 of 1871 patients [25.4%]); the adjusted odds ratio was 0.97 (95% confidence interval, 0.82 to 1.14; P=0.68). EGDT was associated with greater mean (±SD) use of intensive care (5.3±7.1 vs. 4.9±7.0 days, P=0.04) and cardiovascular support (1.9±3.7 vs. 1.6±2.9 days, P=0.01) than was usual care; other outcomes did not differ significantly, although average costs were higher with EGDT. Subgroup analyses showed no benefit from EGDT for patients with worse shock (higher serum lactate level, combined hypotension and hyperlactatemia, or higher predicted risk of death) or for hospitals with a lower propensity to use vasopressors or fluids during usual resuscitation. CONCLUSIONS: In this meta-analysis of individual patient data, EGDT did not result in better outcomes than usual care and was associated with higher hospitalization costs across a broad range of patient and hospital characteristics. (Funded by the National Institute of General Medical Sciences and others; PRISM number, NCT02030158 .).en
dc.description.sponsorshipSupported in part by grants from the U.S. National Institute of General Medical Sciences, National Institutes of Health (P50 GM076659) (ProCESS trial); the National Health and Medical Research Council of Australia (491075 and 1021165), the Intensive Care Foundation, and the Alfred Foundation (ARISE trial); and the United Kingdom National Institute for Health Research Health Technology Assessment Programme (07/37/47) (ProMISe trial)en
dc.publisherMassachusetts Medical Societyen
dc.rightsCopyright © 2017, Massachusetts Medical Society. Deposited with reference to the publisher’s open access archiving policy.en
dc.subjectCardiotonic Agentsen
dc.subjectCombined Modality Therapyen
dc.subjectCost-Benefit Analysisen
dc.subjectErythrocyte Transfusionen
dc.subjectFluid Therapyen
dc.subjectHospital Mortalityen
dc.subjectInfusions, Intravenousen
dc.subjectMiddle Ageden
dc.subjectPractice Guidelines as Topicen
dc.subjectQuality-Adjusted Life Yearsen
dc.subjectRandomized Controlled Trials as Topicen
dc.subjectShock, Septicen
dc.subjectSurvival Analysisen
dc.subjectTreatment Outcomeen
dc.subjectVasoconstrictor Agentsen
dc.titleEarly, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.en
dc.typeJournal Articleen
dc.description.versionPublisher Versionen
dc.type.subtypeJournal Article;Meta-Analysis-
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicineen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciencesen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themesen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themes/Canceren
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themes/Cardiovascularen
pubs.organisational-group/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/Themes/Respiratory Scienceen
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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