Medicine (Austin & Northern Health) - Research Publications
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ItemEffect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock The VITAMINS Randomized Clinical Trial(AMER MEDICAL ASSOC, 2020-02-04)IMPORTANCE: It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock. OBJECTIVE: To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019. INTERVENTIONS: Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days. MAIN OUTCOMES AND MEASURES: The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality. RESULTS: Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported. CONCLUSIONS AND RELEVANCE: In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03333278.
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ItemNo Preview AvailableFunctional Outcomes in Patients Admitted to the Intensive Care Unit with Traumatic Brain Injury and Exposed to Hyperoxia: A Retrospective Multicentre Cohort Study(HUMANA PRESS INC, 2021-04)BACKGROUND: Supplemental oxygen administration to critically ill patients is ubiquitous in the intensive care unit (ICU). Uncertainty persists as to whether hyperoxia is benign in patients with traumatic brain injury (TBI), particularly in regard to their long-term functional neurological outcomes. METHODS: We conducted a retrospective multicenter cohort study of invasively ventilated patients with TBI admitted to the ICU. A database linkage between the Australian and New Zealand Intensive Care Society Adult Patient Database (ANZICS-APD) and the Victorian State Trauma Registry (VSTR) was utilized. The primary exposure variable was minimum acute physiology and chronic health evaluation (APACHE) III PaO2 in the first 24 h of ICU. We defined hypoxia as PaO2 < 60 mmHg, normoxia as 60-299 mmHg, and hyperoxia as ≥ 300 mmHg. The primary outcome was a Glasgow Outcome Scale-Extended (GOSE) < 5 at 6 months while secondary outcomes included 12 and 24 months GOSE and mortality at each of these timepoints. Additional sensitivity analyses were undertaken in the following subgroups: isolated head injury, patients with operative intervention, head injury severity, and PaO2 either subcategorized by increments of 60 mmHg or treated as a continuous variable. RESULTS: A total of 3699 patients met the inclusion criteria. The mean age was 42.8 years, 77.7% were male and the mean acute physiology and chronic health evaluation (APACHE) III score was 60.1 (26.3). 2842 patients experienced normoxia, and 783 hyperoxia. The primary outcome occurred in 1470 (47.1%) of patients overall with 1123 (47.1%) from the normoxia group and 312 (45.9%) from the hyperoxia group-odds ratio 0.99 (0.78-1.25). No significant differences in outcomes between groups at 6, 12, and 24 months were observed. Sensitivity analyses did not identify subgroups that were adversely affected by exposure to hyperoxia. CONCLUSIONS: No associations were observed between hyperoxia in ICU during the first 24 h and adverse neurological outcome at 6 months in ventilated TBI patients.
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ItemThe Australasian Resuscitation In Sepsis Evaluation: Fluids or vasopressors in emergency department sepsis (ARISE FLUIDS), a multi-centre observational study describing current practice in Australia and New Zealand(WILEY, 2020-08)OBJECTIVES: To describe haemodynamic resuscitation practices in ED patients with suspected sepsis and hypotension. METHODS: This was a prospective, multicentre, observational study conducted in 70 hospitals in Australia and New Zealand between September 2018 and January 2019. Consecutive adults presenting to the ED during a 30-day period at each site, with suspected sepsis and hypotension (systolic blood pressure <100 mmHg) despite at least 1000 mL fluid resuscitation, were eligible. Data included baseline demographics, clinical and laboratory variables and intravenous fluid volume administered, vasopressor administration at baseline and 6- and 24-h post-enrolment, time to antimicrobial administration, intensive care admission, organ support and in-hospital mortality. RESULTS: A total of 4477 patients were screened and 591 were included with a mean (standard deviation) age of 62 (19) years, Acute Physiology and Chronic Health Evaluation II score 15.2 (6.6) and a median (interquartile range) systolic blood pressure of 94 mmHg (87-100). Median time to first intravenous antimicrobials was 77 min (42-148). A vasopressor infusion was commenced within 24 h in 177 (30.2%) patients, with noradrenaline the most frequently used (n = 138, 78%). A median of 2000 mL (1500-3000) of intravenous fluids was administered prior to commencing vasopressors. The total volume of fluid administered from pre-enrolment to 24 h was 4200 mL (3000-5661), with a range from 1000 to 12 200 mL. Two hundred and eighteen patients (37.1%) were admitted to an intensive care unit. Overall in-hospital mortality was 6.2% (95% confidence interval 4.4-8.5%). CONCLUSION: Current resuscitation practice in patients with sepsis and hypotension varies widely and occupies the spectrum between a restricted volume/earlier vasopressor and liberal fluid/later vasopressor strategy.