Crit Care Resusc
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Background: Nosocomial pneumonia in the critical care setting is associated with increased morbidity, significant crude mortality rates and high health care costs. Ventilator-associated pneumonia represents about 80% of nosocomial pneumonia cases in intensive care units (ICUs). Wide variance in incidence of nosocomial pneumonia and diagnostic techniques used has been reported, while successful treatment remains complex and a matter of debate. ⋯ The concordance of ventilator-associated pneumonia diagnosis with accepted definitions will also be assessed. Results and conclusions: PneumoINSPIRE will provide valuable information on current diagnostic and management practices relating to ICU nosocomial pneumonia, and identify research priorities in the field. Trial registration:ClinicalTrials.gov identifier NCT02793141.
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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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Objective: To study the temperature and haemodynamic effects of room versus body temperature 20% albumin fluid bolus therapy (FBT). Design: Single-centre, prospective, before-after trial. Setting: A tertiary intensive care unit (ICU) in Australia. ⋯ In addition, mean pulmonary arterial pressure (PAP) (P = 0.002) increased more with body temperature albumin and remained higher for most of the observation period. Conclusion: Compared with room temperature albumin FBT, body temperature 20% albumin FBT prevents FBT-associated blood temperature fall and increases mean PAP. However, CI and MAP changes were the similar between the two groups, implying that fluid temperature has limited haemodynamic effects in these patients.