Articles: critical-care.
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Randomized Controlled Trial Multicenter Study Comparative Study
Critical care management of aneurysmal subarachnoid haemorrhage in Australia and New Zealand: what are we doing, and where to from here?
Patients with an aneurysmal subarachnoid haemorrhage (SAH) frequently require admission to the intensive care unit. There, a variety of therapeutic strategies are initiated, in addition to definitive procedures aimed at securing the aneurysm. Despite a substantial investment in caring for these patients, outcomes for this group remain poor. ⋯ Delayed cerebral ischaemia is a significant cause of longterm morbidity and mortality after SAH. There are limited data supporting much of the critical care provided to patients with SAH in the ICU, leading to substantial institutional and practitioner variation in treatment. Whether this influences patient outcomes is unknown, although it represents a major knowledge gap in neurocritical practice in Australia and New Zealand.
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Practice Guideline Randomized Controlled Trial
Considerations for co-enrolment in randomised controlled effectiveness trials in critical care: the SPICE-8 co-enrolment guidelines.
The Australian and New Zealand Intensive Care Society Clinical Trials Group and other investigator-led trials groups in critical care publish policies and guidelines outlining the rationale for considering co-enrolment in large, randomised controlled trials in intensive care medicine. However, none present a checklist of criteria by which a request for permission to co-enrol in an existing trial can be assessed. ⋯ Reporting co-enrolment in trials, for regulatory purposes and in publications, is uncommon, partly because of the complexity involved in explaining a lack of a plausible coenrolment effect. We suggest that noting compliance with these criteria would simplify such reporting and enhance transparency.
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Randomized Controlled Trial Multicenter Study
Statistical analysis plan for the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial.
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. ⋯ We have developed an SAP for the ADRENAL trial. This plan accords with high-quality standards of internal validity to minimise analysis bias.
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Randomized Controlled Trial
Impact of high-dose vitamin D3 on plasma free 25-hydroxyvitamin D concentrations and antimicrobial peptides in critically ill mechanically ventilated adults.
High-dose vitamin D3 increases plasma total 25-hydroxyvitamin D [25(OH)D] in critically ill, ventilated patients; however, to our knowledge, the effect on plasma levels of free (nonprotein-bound) 25(OH)D has not been investigated in critical illness. Moreover, the relationship of free 25(OH)D and the regulation of endogenous antimicrobial peptides (AMPs) remains unknown. The aims of this study were to determine in critically ill adults with respiratory failure the effect of previous high-dose regimens of vitamin D3 on free 25(OH)D concentrations, the relationship of free 25(OH)D with circulating cathelicidin (LL-37) and human beta-defensin-2 (hBD-2), and the associations between plasma levels of free 25(OH)D and these AMPs to alveolar macrophage phagocytosis function. ⋯ The present study found a dose-related increase in plasma free-25(OH)D levels, which was associated with increasing circulating mRNA expression of hCAP18 over time. There were no correlations between changes in total and free 25(OH)D against plasma LL-37 and hBD-2 concentrations. Larger studies appear warranted to determine the impact of high-dose vitamin D3 administration on endogenous AMPs.
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Randomized Controlled Trial Multicenter Study
Simvastatin for patients with acute respiratory distress syndrome: long-term outcomes and cost-effectiveness from a randomised controlled trial.
Simvastatin therapy for patients with acute respiratory distress syndrome (ARDS) has been shown to be safe and associated with minimal adverse effects, but it does not improve clinical outcomes. The aim of this research was to report on mortality and cost-effectiveness of simvastatin in patients with ARDS at 12 months. ⋯ Simvastatin was found to be cost-effective for the treatment of ARDS, being associated with both a significant QALY gain and a cost saving. There was no significant reduction in mortality at 12 months, TRIAL REGISTRATION: ISRCTN, 88244364. Registered 26 November 2010.