Hydrocortisone Compared with Placebo in Patients with Septic Shock Satisfying the Sepsis-3 Diagnostic Criteria and APROCCHSS Study Inclusion Criteria: A Post Hoc Analysis of the ADRENAL Trial.

Background: Two recent randomized controlled trials (Adjunctive Glucocorticoid Therapy in Patients with Septic Shock [ADRENAL] and Activated Protein C and Corticosteroids for Human Septic Shock [APROCCHSS]) of corticosteroids in patients with septic shock reported different treatment effects on 90-day mortality. Both trials enrolled patients who met the criteria for septic shock using the second international consensus definitions for sepsis and septic shock (Sepsis-2), but the APROCCHSS trial mandated a greater severity of shock as an inclusion criterion.

Methods: The authors conducted post hoc sensitivity analyses of the ADRENAL trial to determine the effects of hydrocortisone versus placebo in subgroups selected using third international consensus definitions for sepsis and septic shock (Sepsis-3) diagnostic criteria or APROCCHSS inclusion criteria.

A protocol for a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis: BLING III.

Background And Rationale: β-Lactam antibiotics display a time-dependent mechanism of action, with evidence suggesting improved outcomes when administering these drugs via continuous infusion compared with standard intermittent infusion. However, there is no phase 3 randomised controlled trial (RCT) evidence to support one method of administration over another in critically ill patients with sepsis.

Design And Setting: The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 RCT to compare continuous infusion with standard intermittent infusion of β-lactam antibiotics in critically ill patients with sepsis.

Adjunctive Glucocorticoid Therapy in Patients with Septic Shock.

Background: Whether hydrocortisone reduces mortality among patients with septic shock is unclear.

Methods: We randomly assigned patients with septic shock who were undergoing mechanical ventilation to receive hydrocortisone (at a dose of 200 mg per day) or placebo for 7 days or until death or discharge from the intensive care unit (ICU), whichever came first. The primary outcome was death from any cause at 90 days.

The Plasma-Lyte 148 v Saline (PLUS) study protocol: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality.

Background: 0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects.

Objective: To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline.

Statistical analysis plan for the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial.

Background: The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial, a 3800-patient, multicentre, randomised controlled trial, will be the largest study to date of corticosteroid therapy in patients with septic shock.

Objective: To describe a statistical analysis plan (SAP) and make it public before completion of patient recruitment and data collection. The SAP will be adhered to for the final data analysis of this trial, to avoid analysis bias arising from knowledge of study findings.

The Australian and New Zealand Intensive Care Society Clinical Trials Group point prevalence program, 2009-2016.

Background: Cross-sectional point prevalence studies collect observational data at a single time point and may be used to facilitate subsequent research hypotheses and discovery.

Methods: We report the process of implementation and substantive outputs of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) point prevalence program, conducted in participating intensive care units from 2009 to 2016.

Results: Seventy-seven of a maximum 197 adult ICUs across Australia and New Zealand participated in 9 specified study days over 18 days of data collection and collected data on 5043 participants, with an average of 44 ICUs per study day.

Temperature management of non-elective intensive care patients without neurological abnormalities: a point prevalence study of practice in Australia and New Zealand.

Objective: To determine the frequency of pharmacological and physical cooling in non-elective general intensive care unit patients without neurological abnormalities in Australia and New Zealand, and to establish the indications for antipyretics, the prevalence of fever, and the methods of temperature measurement.

Design, Setting And Participants: A point prevalence study conducted on two days in 2010, in 38 ICUs in Australia and New Zealand, examining non-elective (emergency) patients admitted with sepsis and other inflammatory abnormalities but without neurological abnormalities.

Results: Of 506 general ICU patients surveyed on the study days, 311 had sepsis or other inflammatory abnormalities and no neurological abnormalities.

Temperature management in patients with acute neurological lesions: an Australian and New Zealand point prevalence study.

Background: Given the scientific uncertainty of the efficacy and safety of normothermia (36.0°C to 37.5°C) on disability and death after acute neurological lesions, we sought to understand how temperature is managed in usual clinical care for this patient population in Australia and New Zealand.

The ADRENAL study protocol: adjunctive corticosteroid treatment in critically ill patients with septic shock.

Background: There is considerable global uncertainty on the role of low-dose corticosteroids in septic shock, which translates into variations in prescribing practices.

Objective: To describe the protocol for a large-scale multicentre randomised controlled trial in critically ill patients with septic shock, comparing the effects of hydrocortisone and placebo (in addition to standard treatment) on 90-day mortality and other outcomes such as shock reversal, duration of mechanical ventilation and quality of life.

Methods: We will recruit 3800 critically ill patients with septic shock treated in an intensive care unit, to concealed, randomised, parallel assignment of hydrocortisone or placebo.

Hydroxyethyl starch or saline for fluid resuscitation in intensive care.

Background: The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.

Methods: We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.

The variation of acute treatment costs of trauma in high-income countries.

Background: In order to assist health service planning, understanding factors that influence higher trauma treatment costs is essential. The majority of trauma costing research reports the cost of trauma from the perspective of the receiving hospital. There has been no comprehensive synthesis and little assessment of the drivers of cost variation, such as country, trauma, subgroups and methods.

Statistical analysis plan for the Crystalloid Versus Hydroxyethyl Starch Trial (CHEST).

Background: The Crystalloid Versus Hydroxyethyl Starch Trial (CHEST) is a 7000-patient, multicentre, randomised controlled trial comparing the effects of 6% hydroxyethyl starch (130/0.4) to normal saline for fluid resuscitation in intensive care patients. The trial design is based on the Saline Versus Albumin Fluid Evaluation (SAFE) study and will be the largest fluid resuscitation trial conducted to date.