Critical Care - Research Publications
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ItemOutcomes following severe septic shock in a cohort of Aboriginal and Torres Strait Islander people: a nested cohort study from the ADRENAL trial(AUSTRALASIAN MED PUBL CO LTD, 2022-03)Objective: To describe the pattern of acute illness and 6-month mortality and health-related quality-of-life outcomes for a cohort of Aboriginal and Torres Strait Islander patients presenting with septic shock. Design: Nested cohort study of Aboriginal and Torres Strait Islander participants recruited to a large randomised controlled trial of corticosteroid treatment in patients with septic shock. Setting: Royal Darwin Hospital, Northern Territory. Participants: All Aboriginal and Torres Strait Islander patients recruited to the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial at Royal Darwin Hospital were compared with a non-Indigenous cohort drawn from the same site, and a cohort matched for age, sex and severity of disease. Main outcome measures: Mortality at 90 days and 6 months, time to shock resolution, mechanical ventilation requirement, renal replacement therapy requirement, and five-domain, five-level EuroQol questionnaire (EQ-5D-5L) score at 6 months. Results: Aboriginal and Torres Strait Islander patients had significantly reduced risk of death at 90 days when compared with non-Indigenous patients recruited to ADRENAL at Royal Darwin Hospital (12/60 v 23/62; adjusted odds ratio, 0.40 [95% CI, 0.17 to 0.94]) which was robust to additional adjustment for baseline covariates (odds ratio, 0.35 [95% CI, 0.14 to 0.90]). When compared with the matched population drawn from the broader ADRENAL cohort, there was no significant difference in 90-day mortality (12/60 v 16/61; adjusted odds ratio, 1.43 [95% CI, 0.60 to 3.39]; P = 0.42). Only nine Aboriginal and Torres Strait Islander patients provided 6-month health-related quality-of-life data. Conclusions: Aboriginal and Torres Strait Islander patients had reduced risk of death at 90 days when compared with non- Indigenous patients recruited to the ADRENAL trial at Royal Darwin Hospital, which was robust to adjustment for covariates, but similar outcomes when compared with a cohort matched for age, sex and severity of disease.
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ItemRapid 500 mL albumin bolus versus rapid 200 mL bolus followed by slower continuous infusion in post-cardiac surgery patients: a pilot before-and-after study(AUSTRALASIAN MED PUBL CO LTD, 2021-09)Objective: To evaluate the haemodynamic effects of rapid fluid bolus therapy (FBT) (500 mL of 4% albumin over several minutes) versus combined FBT (rapid 200 mL FBT followed by a 300 mL infusion over 30 minutes). Design: Single centre, prospective, before-and-after trial. Setting: A tertiary intensive care unit in Australia. Participants: Fifty mechanically ventilated post-cardiac surgery patients. Interventions: Rapid 4% albumin FBT versus combined FBT. Main outcome measures: We recorded haemodynamic parameters from before FBT to 30 minutes after FBT. A mean arterial pressure (MAP) response was defined by a MAP increase > 10%, and a cardiac index (CI) response was defined by a CI increase > 15%. Results: Immediately after rapid FBT versus combined FBT, there was a CI response in 13 patients (52%) compared with five patients (20%) respectively (P = 0.038), and a MAP response in 11 patients (44%) in each group. However, from FBT administration to 30 minutes, there was a time and group interaction such that MAP was higher in the rapid FBT group (P = 0.003), as was the case for central venous pressure (P = 0.002) and mean pulmonary artery pressure (P < 0.001). Body temperature fell immediately and was lower with rapid FBT but became warmer than with combined FBT later (P < 0.001). At 30 minutes, a MAP response was seen in ten patients (40%) compared with nine patients (36%) (P < 0.99) and a CI response was present in eight patients (32%) compared with 11 patients (44%) (P = 0.56) in the rapid versus combined FBT groups respectively. Conclusion: Rapid FBT was superior to combined FBT in terms of mean MAP levels and immediate CI response. However, the number of MAP responders or CI responders was similar at 30 minutes.
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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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ItemThe psychometric properties and minimal clinically important difference for disability assessment using WHODAS 2.0 in critically ill patients(AUSTRALASIAN MED PUBL CO LTD, 2021-03)Objectives: The 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) provides a standardised method for measuring health and disability. This study aimed to determine its reliability, validity and responsiveness and to establish the minimum clinically important difference (MCID) in critically ill patients. Design: Prospective, multicentre cohort study. Setting: Intensive care units of six metropolitan hospitals. Participants: Adults mechanically ventilated for > 24 hours. Main outcome measures: Reliability was assessed by measuring internal consistency. Construct validity was assessed by comparing WHODAS 2.0 scores at 6 months with the EuroQoL visual analogue scale (EQ VAS) and Lawton Instrumental Activities of Daily Living (IADL) scale scores. Responsiveness was evaluated by assessing change over time, effect sizes, and percentage of patients showing no change. The MCID was calculated using both anchor and distribution-based methods with triangulation of results. Main results: A baseline and 6-month WHODAS 2.0 score were available for 448 patients. The WHODAS 2.0 demonstrated good correlation between items with no evidence of item redundancy. Cronbach α coefficient was 0.91 and average split-half coefficient was 0.91. There was a moderate correlation between the WHODAS 2.0 and the EQ VAS scores (r = -0.72; P < 0.001) and between the WHODAS 2.0 and the Lawton IADL scores (r = -0.66; P < 0.001) at 6 months. The effect sizes for change in the WHODAS 2.0 score from baseline to 3 months and from 3 to 6 months were low. Ceiling effects were not present and floor effects were present at baseline only. The final MCID estimate was 10%. Conclusion: The 12-item WHODAS 2.0 is a reliable, valid and responsive measure of disability in critically ill patients. A change in the total WHODAS 2.0 score of 10% represents the MCID.
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ItemEarly metabolic acidosis in critically ill patients: a binational multicentre study(AUSTRALASIAN MED PUBL CO LTD, 2021-03)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. Participants: Adult patients registered to the database from 2008 to 2018. Main outcome measures: Incidence, prevalence, and hospital mortality of patients with MA by the two criteria. Results: We screened 1 076 087 patients. Given the Australian and New Zealand population during the study period, we estimated the incidence of severe MA at 39.5 per million per year versus 349.2–411.5 per million per year for moderate MA. In the most recent 2 years, we observed early severe MA in 1.5% (1350/87 110) of patients compared with 8.4% (20 679/244 740) for moderate MA. 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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ItemDevelopment and Validation of Scores to Predict Prolonged Mechanical Ventilation after Cardiac Surgery(W B SAUNDERS CO-ELSEVIER INC, 2024-02)OBJECTIVES: To optimize the early prediction of prolonged postoperative mechanical ventilation after cardiac surgery (>24 hours postoperatively). DESIGN: The authors performed a retrospective analysis. SETTING: The Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) database was utilized. PARTICIPANTS: All patients included in the ANZSCTS database between January 2015 and December 2018 were analyzed. INTERVENTIONS: No interventions were performed in this observational study. MEASUREMENTS AND MAIN RESULTS: A previously developed model was modified to allow retrospective risk calculation and model assessment (Modified Hessels score). The database was split into development and validation sets. A new risk model was developed using forward and backward stepwise elimination (ANZ-PreVent score). The authors assessed 48,382 patients, of whom 5004 (10.3%) were ventilated mechanically for >24 hours post-operatively. The Modified Hessels score demonstrated good performance in this database, with a c-index of 0.78 (95% CI 0.77-0.78) and a Brier score of 0.08. The newly developed ANZ-PreVent score demonstrated better performance (validation cohort, n = 12,229), with a c-index of 0.84 (95% CI 0.83-0.85) (p < 0.0001) and a Brier score of 0.07. Both scores performed better than the severity of illness scores commonly used to predict outcomes in intensive care. CONCLUSIONS: The authors validated a modified version of an existing prediction score and developed the ANZ-PreVent score, with improved performance for identifying patients at risk of ventilation for >24 hours. The improved score can be used to identify high-risk patients for targeted interventions in future randomized controlled trials.
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ItemNo Preview AvailableMild Hypercapnia or Normocapnia after Out-of-Hospital Cardiac Arrest(MASSACHUSETTS MEDICAL SOC, 2023-07-06)BACKGROUND: Guidelines recommend normocapnia for adults with coma who are resuscitated after out-of-hospital cardiac arrest. However, mild hypercapnia increases cerebral blood flow and may improve neurologic outcomes. METHODS: We randomly assigned adults with coma who had been resuscitated after out-of-hospital cardiac arrest of presumed cardiac or unknown cause and admitted to the intensive care unit (ICU) in a 1:1 ratio to either 24 hours of mild hypercapnia (target partial pressure of arterial carbon dioxide [Paco2], 50 to 55 mm Hg) or normocapnia (target Paco2, 35 to 45 mm Hg). The primary outcome was a favorable neurologic outcome, defined as a score of 5 (indicating lower moderate disability) or higher, as assessed with the use of the Glasgow Outcome Scale-Extended (range, 1 [death] to 8, with higher scores indicating better neurologic outcome) at 6 months. Secondary outcomes included death within 6 months. RESULTS: A total of 1700 patients from 63 ICUs in 17 countries were recruited, with 847 patients assigned to targeted mild hypercapnia and 853 to targeted normocapnia. A favorable neurologic outcome at 6 months occurred in 332 of 764 patients (43.5%) in the mild hypercapnia group and in 350 of 784 (44.6%) in the normocapnia group (relative risk, 0.98; 95% confidence interval [CI], 0.87 to 1.11; P = 0.76). Death within 6 months after randomization occurred in 393 of 816 patients (48.2%) in the mild hypercapnia group and in 382 of 832 (45.9%) in the normocapnia group (relative risk, 1.05; 95% CI, 0.94 to 1.16). The incidence of adverse events did not differ significantly between groups. CONCLUSIONS: In patients with coma who were resuscitated after out-of-hospital cardiac arrest, targeted mild hypercapnia did not lead to better neurologic outcomes at 6 months than targeted normocapnia. (Funded by the National Health and Medical Research Council of Australia and others; TAME ClinicalTrials.gov number, NCT03114033.).
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ItemNo Preview AvailableA multicentre point prevalence study of delirium assessment and management in patients admitted to Australian and New Zealand intensive care units(AUSTRALASIAN MED PUBL CO LTD, 2020-12)Objective: To characterise the assessment and management of delirium in patients admitted to intensive care units (ICUs) in Australia and New Zealand. Methods: We conducted a multicentre observational point prevalence study across 44 adult Australian and New Zealand ICUs. Data were extracted for all patients in the ICU in terms of assessment and treatment of delirium. ICU-level data were collected regarding the use of explicit protocols related to delirium. Results: We studied 627 patients, with 54% (336/627) having at least one delirium screening assessment performed. The Confusion Assessment Method for the ICU (CAM-ICU) was the most frequently used tool (88%, 296/336). Of patients assessed, 20% (68) were identified to have delirium. Eighteen per cent (111) of patients were administered a drug to manage delirium, with 41% (46) of those receiving a drug having no recorded assessment for delirium on that day. Of the drugs used to treat delirium, quetiapine was the most frequently administered. Physical restraints were applied to 8% (48/626) of patients, but only 17% (8/48) of such patients had been diagnosed with delirium. Most physically restrained patients either did not have delirium diagnosed (31%, 15/48) or had no formal assessment recorded (52%, 25/48) on that day. Conclusions: On the study day, more than 50% of patients had a delirium screening assessment performed, with 20% of screened patients deemed to have delirium. Drugs that are prescribed to treat delirium and physical restraints were frequently used in the absence of delirium or the formal assessment for its presence.
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ItemNo Preview AvailableNature and impact of in-hospital complications associated with persistent critical illness(AUSTRALASIAN MED PUBL CO LTD, 2020-12)Background: Persistent critical illness (PerCI) is defined as an intensive care unit (ICU) admission lasting ≥ 10 days. The in-hospital complications associated with its development are poorly understood. Aims: To test whether PerCI is associated with a greater prevalence, rate and specific types of in-hospital complications. Methods: Single-centre, retrospective, observational case-control study. Results: We studied 1200 patients admitted to a tertiary ICU from 2010 to 2015. Median ICU length of stay was 16 days (interquartile range [IQR], 12-23) for PerCI patients v 2.3 days (IQR, 1.1-3.7) for controls, and median hospital length of stay was 41 days (IQR, 22-75) v 8 days (IQR, 4-17) respectively. A greater proportion of PerCI patients received acute renal replacement therapy (37% v 6.8%) or underwent reintubation (17% v 1%) and/or tracheostomy (36% v 0.6%); P < 0.0001. Despite these complications, PerCI patients had similar hospital mortality (29% v 27%; P = 0.53). PerCI patients experienced a greater absolute number of complications (12.1 v 4.0 complications per patient; P < 0.0001) but had fewer exposure-adjusted complications (202 v 272 complications per 1000 hospital bed-days; P < 0.001) and a particularly high overall prevalence of specific complications. Conclusions: PerCI patients experience a higher prevalence, but not a higher rate, of exposure-adjusted complications. Some of these complications appear amenable to prevention, helping to define intervention targets in patients at risk of PerCI. Funding: Austin Hospital Intensive Care Trust Fund.
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ItemNo Preview AvailableStudy protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial(AUSTRALASIAN MED PUBL CO LTD, 2020-06)BACKGROUND: Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes. OBJECTIVE: To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L). MAIN OUTCOME MEASURES: The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. RESULTS AND CONCLUSION: The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised. TRIAL REGISTRATION: This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.