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PurposeTo assess the impact of gender and pre-menopausal state on short- and long-term outcomes in patients with septic shock.Material and methodsCohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial, an international randomized controlled trial comparing early goal-directed therapy (EGDT) to usual care in patients with early septic shock, conducted between October 2008 and April 2014. The primary exposure in this analysis was legal gender and the secondary exposure was pre-menopausal state defined by chronological age (≤ 50 years).Results641 (40.3%) of all 1591 ARISE trial participants in the intention-to-treat population were females and overall, 337 (21.2%) (146 females) patients were 50  years of age or younger. After risk-adjustment, we could not identify any survival benefit for female patients at day 90 in the younger (≤50 years) (adjusted Odds Ratio (aOR): 0.91 (0.46-1.89), p = .85) nor in the older (>50 years) age-group (aOR: 1.10 (0.81-1.49), p = .56). Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures.ConclusionsThis post-hoc analysis of a large multi-center trial in early septic shock has shown no short- or long-term survival effect for women overall as well as in the pre-menopausal age-group.

Original publication

DOI

10.1016/j.jcrc.2019.11.002

Type

Journal

Journal of critical care

Publication Date

02/2020

Volume

55

Pages

177 - 183

Addresses

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. Electronic address: nora.luethi@insel.ch.

Keywords

ARISE investigators, Humans, Shock, Septic, Treatment Outcome, Resuscitation, Proportional Hazards Models, Odds Ratio, Prospective Studies, Sex Factors, Premenopause, Quality of Life, Adult, Aged, Middle Aged, Female, Male, Kaplan-Meier Estimate, Early Goal-Directed Therapy