Crit Care Resusc
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Randomized Controlled Trial Multicenter Study Comparative Study
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial.
The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown. ⋯ The BaSICS trial will provide robust evidence on whether a balanced crystalloid, compared with saline, improves important patient outcomes in critically ill patients. BaSICS will also provide relevant information on whether bolus infusion rate affects outcomes in this population.
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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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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
Quality sleep using earplugs in the intensive care unit: the QUIET pilot randomised controlled trial.
To assess the feasibility of a definitive, randomised controlled trial of earplugs as a noise-abatement strategy to improve sleep and reduce delirium in patients admitted to the intensive care unit. ⋯ A definitive study of earplugs as a noiseabatement strategy for patients admitted to the ICU is feasible on the basis of participant acceptability of the intervention and protocol compliance.
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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.