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Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.
Rowan, Kathryn M; Angus, Derek C; Bailey, Michael; Barnato, Amber E; Bellomo, Rinaldo; Canter, Ruth R; Coats, Timothy J; Delaney, Anthony; Gimbel, Elizabeth; Grieve, Richard D; Harrison, David A; Higgins, Alisa M; Howe, Belinda; Huang, David T; Kellum, John A; Mouncey, Paul R; Music, Edvin; Peake, Sandra L; Pike, Francis; Reade, Michael C; Sadique, M Zia; Singer, Mervyn; Yealy, Donald M.
Afiliação
  • Rowan KM; Intensive Care National Audit and Research Centre, London, United Kingdom
  • Angus DC; University of Pittsburgh School of Medicine, Pittsburgh
  • Bailey M; Monash University, Melbourne, VIC, Australia
  • Barnato AE; University of Pittsburgh School of Medicine, Pittsburgh
  • Bellomo R; Monash University, Melbourne, VIC, Australia
  • Canter RR; Intensive Care National Audit and Research Centre, London, United Kingdom
  • Coats TJ; University of Leicester, Leicester, United Kingdom
  • Delaney A; University of Sydney, Sydney, Australia
  • Gimbel E; University of Pittsburgh School of Medicine, Pittsburgh
  • Grieve RD; London School of Hygiene and Tropical Medicine, London, United Kingdom
  • Harrison DA; Intensive Care National Audit and Research Centre, London, United Kingdom
  • Higgins AM; Monash University, Melbourne, VIC, Australia
  • Howe B; Monash University, Melbourne, VIC, Australia
  • Huang DT; University of Pittsburgh School of Medicine, Pittsburgh
  • Kellum JA; University of Pittsburgh School of Medicine, Pittsburgh
  • Mouncey PR; Intensive Care National Audit and Research Centre, London, United Kingdom
  • Music E; University of Pittsburgh School of Medicine, Pittsburgh
  • Peake SL; Monash University, Melbourne, VIC, Australia
  • Pike F; University of Adelaide, Adelaide, SA, Australia
  • Reade MC; Queen Elizabeth Hospital, Adelaide, SA, Australia
  • Sadique MZ; Eli Lilly, Indianapolis
  • Singer M; University of Queensland, Brisbane, Australia
  • Yealy DM; London School of Hygiene and Tropical Medicine, London, United Kingdom
N Engl J Med ; 376(23): 2223-2234, 2017 06 08.
Article em En | MEDLINE | ID: mdl-28320242
BACKGROUND: 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 ClinicalTrials.gov number, NCT02030158 .).
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ressuscitação / Choque Séptico / Vasoconstritores / Transfusão de Eritrócitos / Hidratação Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Systematic_reviews Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ressuscitação / Choque Séptico / Vasoconstritores / Transfusão de Eritrócitos / Hidratação Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Systematic_reviews Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2017 Tipo de documento: Article