Show simple item record

Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.

dc.contributor.author PRISM Investigators
dc.contributor.author Rowan, Kathryn M
dc.contributor.author Angus, Derek C
dc.contributor.author Bailey, Michael
dc.contributor.author Barnato, Amber E
dc.contributor.author Bellomo, Rinaldo
dc.contributor.author Canter, Ruth R
dc.contributor.author Coats, Timothy J
dc.contributor.author Delaney, Anthony
dc.contributor.author Gimbel, Elizabeth
dc.contributor.author Grieve, Richard D
dc.contributor.author Harrison, David A
dc.contributor.author Higgins, Alisa M
dc.contributor.author Howe, Belinda
dc.contributor.author Huang, David T
dc.contributor.author Kellum, John A
dc.contributor.author Mouncey, Paul R
dc.contributor.author Music, Edvin
dc.contributor.author Peake, Sandra L
dc.contributor.author Pike, Francis
dc.contributor.author Reade, Michael C
dc.contributor.author Sadique, M Zia
dc.contributor.author Singer, Mervyn
dc.contributor.author Yealy, Donald M
dc.date.accessioned 2020-08-30T16:12:10Z
dc.date.available 2020-08-30T16:12:10Z
dc.date.issued 2017-06
dc.identifier.issn 0028-4793
dc.identifier.issn 1533-4406
dc.identifier.uri https://hdl.handle.net/10161/21358
dc.description.abstract 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 .).
dc.language eng
dc.publisher Massachusetts Medical Society
dc.relation.ispartof The New England journal of medicine
dc.relation.isversionof 10.1056/nejmoa1701380
dc.subject PRISM Investigators
dc.subject Humans
dc.subject Shock, Septic
dc.subject Cardiotonic Agents
dc.subject Vasoconstrictor Agents
dc.subject Treatment Outcome
dc.subject Erythrocyte Transfusion
dc.subject Combined Modality Therapy
dc.subject Fluid Therapy
dc.subject Resuscitation
dc.subject Hospitalization
dc.subject Infusions, Intravenous
dc.subject Hospital Mortality
dc.subject Survival Analysis
dc.subject Quality-Adjusted Life Years
dc.subject Aged
dc.subject Middle Aged
dc.subject Cost-Benefit Analysis
dc.subject Female
dc.subject Male
dc.subject Randomized Controlled Trials as Topic
dc.subject Practice Guidelines as Topic
dc.title Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.
dc.type Journal article
dc.date.updated 2020-08-30T16:12:10Z
pubs.begin-page 2223
pubs.end-page 2234
pubs.issue 23
pubs.organisational-group School of Medicine
pubs.organisational-group Surgery, Emergency Medicine
pubs.organisational-group Duke
pubs.organisational-group Surgery
pubs.organisational-group Clinical Science Departments
pubs.publication-status Published
pubs.volume 376


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record