Crit Care Resusc
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Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. ⋯ The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.
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Objective: We aimed to measure the incidence, prevalence, characteristics and outcomes of intensive care unit (ICU) patients with early (first 24 hours) metabolic acidosis (MA) according to two different levels of severity with a focus on recent data. Design: We retrospectively applied two diagnostic criteria to our analysis based on literature for early MA: i) severe MA criteria (pH ≤ 7.20 and Paco2 ≤ 45 mmHg and HCO3- ≤ 20 mmol/L with total Sequential Organ Failure Assessment [SOFA] score ≥ 4 or lactate ≥ 2 mmol/L), and ii) moderate MA criteria (pH < 7.30 and base excess < -4 mmol/L and Paco2 ≤ 45 mmHg). Setting: ICUs in the Australian and New Zealand Intensive Care Society Adult Patient Database program. ⋯ Overall, hospital mortality for patients with early severe MA was 48.3% (652/1350) compared with 21.5% (4444/20 679) for moderate MA. Conclusions: Early severe MA is uncommon in Australian and New Zealand ICUs and carries a very high mortality. Moderate MA is over seven-fold more common and still carries a high mortality.
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Background: The NITric oxide during cardiopulmonary bypass (CPB) to improve Recovery in Infants with Congenital heart defects (NITRIC) trial, a 1320-patient, multicentre, randomised controlled trial, is aiming to improve survival free of ventilation after CPB by using nitric oxide delivered into the oxygenator of the CPB. Objective: To provide a statistical analysis plan before completion of patient recruitment and data monitoring. Final analyses for this study will adhere to this statistical analysis plan, which details all key pre-planned analyses. ⋯ Conclusion: The statistical analysis plan for the NITRIC trial establishes detailed pre-planned analyses alongside Stata scripts to analyse the largest trial in the field of neonatal and paediatric heart surgery. The plan ensures standards for trial analysis validity aiming to minimise bias of analyses. Trial registration: ACTRN12617000821392.
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Introduction: Fewer women than men are admitted to intensive care units (ICUs) worldwide. Objectives: To quantify the relative contribution of each major diagnostic category to the overall sex balance in ICU admissions in Australia and New Zealand, and to describe changes in the sex balance over time and with patient age. Methods: Retrospective cross-sectional study of Australian and New Zealand ICU admissions recorded in the Australian and New Zealand Intensive Care Society Adult Patient Database between 2005 and 2018. ⋯ Conclusion: There is a significant sex imbalance in ICU admissions in Australia and New Zealand, widespread across the diagnostic categories. Cardiovascular admissions contribute most to the observed preponderance of men. The proportion of female ICU patients is steadily increasing.
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Objective: Examine values, preferences and goals elicited by doctors following goals-of-care (GOC) discussions with critically ill patients who had life-limiting illnesses. Design: Descriptive qualitative study using four-stage latent content analysis. Setting: Tertiary intensive care unit (ICU) in South Western Victoria. ⋯ The subthemes - relationships, sense of place, enjoyment of activities, independence, dignity, cognitive function, quality of life, longevity and physical comfort - provided a matrix of issues identified as important to patients. Relationship, place, independence and physical comfort statements were most frequently identified; longevity was least frequently identified. Conclusion: Our analysis of GOC discussions between medical staff and patients who had life-limiting illnesses and were admitted to the ICU, using a shared decision-making training and support program, revealed a framework of values, preferences and goals that could provide a structure to assist clinicians to engage in shared decision making.