Critical Care - Research Publications
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ItemProtocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial(AUSTRALASIAN MED PUBL CO LTD, 2021-09)Objective: To describe the protocol and statistical analysis plan for the Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. Design: An international, multicentre, parallel-group, randomised controlled phase 3 trial. Setting: Intensive care units (ICUs) in Australia, New Zealand, Germany, Ireland, the United Kingdom and Brazil. Patients: 750 adult patients expected to receive mechanical ventilation for more than 48 hours. Interventions: Early activity and mobilisation delivered to critically ill patients in an ICU for up to 28 days compared with standard care. Main outcome measures: The primary outcome is the number of days alive and out of hospital at 180 days after randomisation. Secondary outcomes include ICU-free days, ventilator-free days, delirium-free days, all-cause mortality at 28 and 180 days after randomisation, and functional outcome at 180 days after randomisation. Results: Recruitment at 46 research sites passed 576 patients in March 2021. Final collection of all 180-day outcome data for the target of 750 patients is anticipated by May 2022. Conclusions: Consistent with international guidelines, a detailed protocol and prospective analysis plan has been developed for the TEAM III trial. This plan specifies the statistical models for evaluating primary and secondary outcomes, defines covariates for adjusted analyses, and defines methods for exploratory analyses. Application of this protocol and statistical analysis plan to the forthcoming TEAM III trial will facilitate unbiased analyses of the clinical data collected. Trial registration:ClinicalTrials.gov identifier NCT03133377.
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ItemStudy protocol for TARGET protein: The effect of augmented administration of enteral protein to critically ill adults on clinical outcomes: A cluster randomised, cross-sectional, double cross-over, clinical trial(ELSEVIER, 2023-09)BACKGROUND: It is unknown whether increasing dietary protein to 1.2-2.0 g/kg/day as recommended in international guidelines compared to current practice improves outcomes in intensive care unit (ICU) patients. The TARGET Protein trial will evaluate this. OBJECTIVE: To describe the study protocol for the TARGET Protein trial. DESIGN SETTING AND PARTICIPANTS: TARGET Protein is a cluster randomised, cross-sectional, double cross-over, pragmatic clinical trial undertaken in eight ICUs in Australia and New Zealand. Each ICU will be randomised to use one of two trial enteral formulae for three months before crossing over to the other formula, which is then repeated, with enrolment continuing at each ICU for 12 months. All patients aged ≥16 years in their index ICU admission commencing enteral nutrition will be eligible for inclusion. Eligible patients will receive the trial enteral formula to which their ICU is allocated. The two trial enteral formulae are isocaloric with a difference in protein dose: intervention 100g/1000 ml and comparator 63g/1000 ml. Staggered recruitment commenced in May 2022. MAIN OUTCOMES MEASURES: The primary outcome is days free of the index hospital and alive at day 90. Secondary outcomes include days free of the index hospital at day 90 in survivors, alive at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination. CONCLUSION: TARGET Protein aims to determine whether augmented enteral protein delivery reduces days free of the index hospital and alive at day 90. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621001484831).
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ItemAdministration of pharmacological sleep aids prior to, during and following critical illness(WILEY, 2022-11)BACKGROUND: Sleep in the intensive care unit (ICU) is frequently disturbed and this may have a detrimental effect on recovery. AIM: To determine the use of pharmacological sleep aids in critically ill patients prior to, during and after ICU admission. METHODS: We conducted a single-centre period prevalence study of all adult patients admitted to a university-associated adult medical-surgical ICU for more than two nights in a 3-month period ending September 2019. The major outcome of interest was the proportion of ICU patients who had a pharmacological sleep aid administered prior to, during and after ICU admission. Associations of selected patient variables with sleep aid prescription in the ICU were summarised both as unadjusted univariable comparisons and as adjusted effect estimates returned by a multivariable logistic regression model. RESULTS: During the study period, 370 patients met all eligibility criteria. A pharmacological sleep aid was identified prior to hospital admission in 34 (9%) patients and in 62 (17%) patients during ICU admission. Of the 340 ICU survivors, 292 remained in the same hospital. Of these, 96 (33%) received a pharmacological sleep aid at least once during their post-ICU general hospital ward stay. Pre-hospital sleep aid use, male sex, longer ICU admission and higher APACHE (Acute Physiology and Chronic Health Evaluation) III scores were associated with sleep aid prescription in the ICU. CONCLUSIONS: Pharmacological sleep aids are administered frequently in the ICU with administration increasing substantially after ICU discharge.
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ItemIntensive care unit trainee perception of end-of-life care provided during medical emergency team activation events(WILEY, 2022-06)BACKGROUND: Hospital medical emergency team (MET) activation events involving end-of-life care (EOLC) are common. The issues faced by medical staff attending these events are incompletely described. AIMS: The purpose of this study was to measure the perceptions of Victorian hospital medical staff, training in the speciality of intensive care, about multiple aspects of EOLC MET calls. We sought to determine the overall extent of formal training in MET and EOLC and assess the domains of self-perceived confidence, barriers to communication, frequency of clinician agreement and trainee distress. METHODS: We conducted an anonymous, voluntary, Internet-based survey of registered trainees of the College of Intensive Care Medicine of Australia and New Zealand in May 2019. The participants eligible were those trainees working in an adult intensive care unit in Victoria, Australia, during the study period. The main outcome measures were self-reported levels of confidence, barriers to communication, frequency of conflict and distress, senior support, supervision and access to training. RESULTS: Of 124 trainees surveyed, 75 (60%) responded. Overall, 78% of respondents felt confident to manage EOLC MET calls, but the frequently reported barriers to effective patient/next of kin communication included: (i) lack of private meeting rooms; (ii) resource and time constraints; and (iii) lack of patient and family availability during a MET call to discuss medical treatment limitations. Two-thirds of respondents reported emotional distress at least occasionally, this being frequent in one in five. Most (68%) trainees experienced conflict with other medical teams at least occasionally. Factors associated with experiencing distress at least occasionally include greater trainee age, patients' being unable to participate in discussion due to illness, resource and time constraints and negative encounters with other medical teams. CONCLUSIONS: Victorian intensive care trainees were confident managing EOLC MET activation events. However, distress was reported commonly and strategies are required to address the areas of concern.
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Itemβ-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial)(BMC, 2022-01-31)BACKGROUND: There are no therapies proven to diminish the muscle wasting that occurs in patients after major trauma who are admitted to the intensive care unit (ICU). β-Hydroxy-β-methylbutyrate (HMB) is a nutrition intervention that may attenuate muscle loss and, thereby, improve recovery. The primary aim of this study is to determine the feasibility of a blinded randomised clinical trial of HMB supplementation to patients after major trauma who are admitted to the ICU. Secondary aims are to establish estimates for the impact of HMB when compared to placebo on muscle mass and nutrition-related patient outcomes. METHODS: This prospective, single-centre, blinded, randomised, placebo-controlled, parallel-group, feasibility trial with allocation concealment will recruit 50 participants over 18 months. After informed consent, participants will be randomised [1:1] to receive either the intervention (three grams of HMB dissolved in either 150 ml of orange juice for those allowed oral intake or 150 ml of water for those being enterally fed) or placebo (150 ml of orange juice for those allowed oral intake or 150 ml of water for those being enterally fed). The intervention will be commenced in ICU, continued after ICU discharge and ceased at hospital discharge or day 28 post randomisation, whichever occurs first. The primary outcome is the feasibility of administering the intervention. Secondary outcomes include change in muscle thickness using ultrasound and other nutritional and patient-centred outcomes. DISCUSSION: This study aims to determine the feasibility of administering HMB to critically ill multi-trauma patients throughout ICU admission until hospital discharge. Results will inform design of a larger randomised clinical trial. TRIAL REGISTRATION: The protocol is registered with Australian New Zealand Clinical Trials Registry (ANZCTR) ANZCTR: 12620001305910 . UTN: U1111-1259-5534.
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ItemCardiac ischemia in patients with septic shock randomized to vasopressin or norepinephrine (vol 17, R117, 2013)(BIOMED CENTRAL LTD, 2017-05-04)
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ItemNo Preview AvailableCost-Effectiveness of Erythropoietin in Traumatic Brain Injury: A Multinational Trial-Based Economic Analysis(MARY ANN LIEBERT, INC, 2019-09-01)The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). Unadjusted mean quality-adjusted life-years (QALYs; 95% confidence interval [CI]) at 6 months were 0.027 (0.020-0.034; p < 0.001) higher in the EPO group, with an adjusted QALY increment of 0.014 (0.000-0.028; p = 0.04). Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.
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ItemNo Preview AvailableVenous thromboembolic events in critically ill traumatic brain injury patients(SPRINGER, 2017-03)PURPOSE: To estimate the prevalence, risk factors, prophylactic treatment and impact on mortality for venous thromboembolism (VTE) in patients with moderate to severe traumatic brain injury (TBI) treated in the intensive care unit. METHODS: A post hoc analysis of the erythropoietin in traumatic brain injury (EPO-TBI) trial that included twice-weekly lower limb ultrasound screening. Venous thrombotic events were defined as ultrasound-proven proximal deep venous thrombosis (DVT) or clinically detected pulmonary embolism (PE). Results are reported as events, percentages or medians and interquartile range (IQR). Cox regression analysis was used to calculate adjusted hazard ratios (HR) with 95% confidence intervals (CI) for time to VTE and death. RESULTS: Of 603 patients, 119 (19.7%) developed VTE, mostly comprising DVT (102 patients, 16.9%) with a smaller number of PE events (24 patients, 4.0%). Median time to DVT diagnosis was 6 days (IQR 2-11) and to PE diagnosis 6.5 days (IQR 2-16.5). Mechanical prophylaxis (MP) was used in 91% of patients on day 1, 97% of patients on day 3 and 98% of patients on day 7. Pharmacological prophylaxis was given in 5% of patients on day 1, 30% of patients on day 3 and 57% of patients on day 7. Factors associated with time to VTE were age (HR per year 1.02, 95% CI 1.01-1.03), patient weight (HR per kg 1.01, 95% CI 1-1.02) and TBI severity according to the International Mission for Prognosis and Analysis of Clinical Trials risk of poor outcome (HR per 10% increase 1.12, 95% CI 1.01-1.25). The development of VTE was not associated with mortality (HR 0.92, 95% CI 0.51-1.65). CONCLUSIONS: Despite mechanical and pharmacological prophylaxis, VTE occurs in one out of every five patients with TBI treated in the ICU. Higher age, greater weight and greater severity of TBI increase the risk. The development of VTE was not associated with excess mortality.
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ItemMeasuring nutrition-related outcomes in a cohort of multi-trauma patients following intensive care unit discharge(WILEY, 2020-06)BACKGROUND: Functional recovery is an important outcome for those who survive critical illness. The present study aimed to assess nutrition provision and nutrition-related outcomes in a multi-trauma cohort following intensive care unit (ICU) discharge. METHODS: The present study investigated a prospective cohort of patients discharged from an ICU, who had been admitted because of major trauma and required mechanical ventilation for at least 48 h. Nutrition-related outcomes, including body weight, quadriceps muscle layer thickness (QMLT), handgrip strength and subjective global assessment, were recorded on ICU discharge, days 5-7 post-ICU discharge and then weekly until hospital discharge. Nutrition intake was recorded for 5 days post-ICU discharge. Unless otherwise stated, data are presented as the mean (SD). RESULTS: Twenty-eight patients [75% males, 55 (22.5) years] were included. Intake met 64% (28%) of estimated energy and 72% (32%) of protein requirements over the 5 days post-ICU discharge, which was similar to over the ICU admission. From ICU admission to hospital discharge, the mean reduction in weight was 4.2 kg (95% confidence interval = 2.2-6.3, P < 0.001) and after ICU discharge, the mean reduction in weight and QMLT was 2.6 kg (95% confidence interval = 1.0-4.2, P = 0.004) and 0.23 cm (95% confidence interval = 0.06-0.4, P = 0.01), respectively. CONCLUSIONS: Patients received less energy and protein than estimated requirements after ICU discharge. Weight loss and reduction in QMLT also occurred during this period.
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ItemSystematic Review With Meta-Analysis of Patient-Centered Outcomes, Comparing International Guideline-Recommended Enteral Protein Delivery With Usual Care(WILEY, 2020-05)BACKGROUND: International guidelines recommend that protein be administered enterally to critically ill patients at doses between 1.2 and 2 g/kg per day Observational data indicate that patients frequently receive less protein. The aim of this systematic review was to evaluate patient-centered outcomes with guideline-recommended enteral protein compared with usual care. METHODS: A systematic review was performed of randomized controlled trials including critically ill adult patients provided predominately enteral nutrition with mean protein at ≥1.2 g/kg per day (intervention) and <1.2 g/kg per day (comparator). Random-effects models were applied for outcomes reported in ≥3 trials. RESULTS: Of 1375 abstracts, 69 full-text articles were reviewed, and 6 trials meet the inclusion criteria, including 511 patients. The intervention group received a mean (SD) of 1.3 (0.08) g/kg per day, and the comparator group received 0.75 (0.15) g/kg per day protein. Insufficient data were available for meta-analyses on the primary outcome (muscle mass or strength). According to our meta-analyses, mortality at 28 days (5 studies) (risk ratio 0.92 [95% Cl 0.63-1.35], P = .66) and the durations of intensive care unit (6 studies) and hospital admission (4 studies) were similar between the intervention and comparator, with some uncertainty due to sample sizes and heterogeneity. CONCLUSION: There are insufficient data to conclude whether protein provision within the current international guideline recommendations improves outcomes. In a limited dataset, enteral protein intakes near the lower level of current recommendations do not appear to reduce admission duration or mortality when compared with usual care in critically ill.