Articles: sepsis.
-
Randomized Controlled Trial
Comparison of clinical outcomes between intermittent and continuous monitoring of central venous oxygen saturation (ScvO2) in patients with severe sepsis and septic shock: a pilot study.
The Surviving Sepsis Campaign (SSC) to improve patient outcomes in severe sepsis and septic shock contains recommendations for protocolised resuscitation including early goal-directed therapy (EGDT) resuscitation. In EGDT, central venous oxygen saturation (ScvO2) is measured as the target monitoring value. The objective of this study was to determine whether intermittent measurement of ScvO2 is as clinically effective as continuous monitoring in EGDT implementation. ⋯ During EGDT, intermittent ScvO2 monitoring was not inferior to continuous ScvO2 monitoring when delivered within the first 6 h of intervention.
-
Intensive care medicine · Nov 2013
Randomized Controlled TrialEffects of hydroxyethyl starch in subgroups of patients with severe sepsis: exploratory post-hoc analyses of a randomised trial.
It has been speculated that certain subgroups of sepsis patients may benefit from treatment with hydroxyethyl starch (HES) 130/0.42, specifically in the earlier resuscitation of patients with more severely impaired circulation. ⋯ The increased 90-day mortality observed in patients with severe sepsis resuscitated with HES 130/0.42 did not appear to depend on time course, surgery or fluids given prior to randomisation or on markers of shock at randomisation. As the analyses were planned post hoc and their power is reduced, the results should be interpreted with caution.
-
J. Infect. Chemother. · Oct 2013
Randomized Controlled Trial Multicenter StudyA Phase II study of polyclonal anti-TNF-α (AZD9773) in Japanese patients with severe sepsis and/or septic shock.
Because tumor necrosis factor-alpha (TNF-α) induces many of the pathophysiological signs and symptoms observed in sepsis, it is a potential therapeutic target for treatment. The primary objective of this study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple intravenous (i.v.) infusions of two doses of AZD9773 in Japanese patients with severe sepsis and/or septic shock. In this Phase II, double-blind, placebo-controlled, dose-escalation study (ClinicalTrials.gov Identifier: NCT01144624), Japanese patients were randomized to two successive treatment cohorts (cohort 1, loading/maintenance doses of 250/50 U/kg or placebo; cohort 2, loading/maintenance doses of 500/100 U/kg or placebo) for a 5-day treatment period, then a follow-up period to day 29. ⋯ Treatment with AZD9773 led to a decrease in TNF-α concentrations, which was more discernible in the AZD9773 cohort 2; TNF-α concentrations generally decreased with time in patients receiving placebo. A similar pattern of response was observed with interleukin-6 (IL-6) and IL-8. AZD9773 was generally well tolerated with dose-proportional pharmacokinetics in Japanese patients with severe sepsis/septic shock.
-
Randomized Controlled Trial Comparative Study
Enhanced vascular endothelial growth factor and inflammatory cytokine removal with online hemodiafiltration over high-flux hemodialysis in sepsis-related acute kidney injury patients.
Hypercytokinemia plays a central role in pathogenesis and is related to the high mortality in sepsis-related acute kidney injury (AKI). Besides the established cytokines, vascular endothelial growth factor (VEGF) is demonstrated as an important factor in enhancing vascular leakage in sepsis. This prospective randomized trial was conducted to compare the efficacy of cytokine removal between online hemodiafiltration (HDF), which combines convective and diffusive solute removal, and high-flux hemodialysis (HD). ⋯ Online HDF revealed better renal recovery and shorter length of hospitalization than high-flux HD. In conclusion, online HDF in sepsis-related AKI could provide significantly better removal of VEGF and other cytokines and these were associated with better renal outcome than high-flux HD. Thus, online HDF would offer a potential role in hypercytokinemic state in sepsis-related AKI.
-
Emerg Med Australas · Oct 2013
Randomized Controlled Trial Multicenter StudyAustralasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.
The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. ⋯ A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials.