Early and sustained Lactobacillus plantarum probiotic therapy in critical illness: the randomised, placebo-controlled, restoration of gut microflora in critical illness trial (ROCIT).

PURPOSE: In adults requiring treatment in an intensive care unit, probiotic therapy using Lactobacillus plantarum 299v may reduce nosocomial infection. The aim of this study was to determine whether early and sustained L. plantarum 299v therapy administered to adult ICU patients increased days alive and at home. METHODS: A multicentre, parallel group, placebo-controlled, randomised clinical trial was conducted. Adult patients within 48 h of intensive care admission and expected to require intensive care beyond the day after recruitment were eligible to participate. L plantarum 299v or placebo were administered immediately after enrolment and continued for 60 days. The primary outcome was days alive and out of hospital to Day 60 (DAOH60). Secondary outcomes included nosocomial infections. RESULTS: The median [interquartile range (IQR)] number of DAOH60 in the probiotic (n = 110) and placebo group (n = 108) was 49.5 (IQR 37.0-53.0) and 49.0 (IQR 43.8-53.0) respectively, between-group difference of 0.0 [95% confidence interval (CI) - 6.10 to 7.1, P = 0.55]. Nosocomial infection occurred in 8 (7.3%) and 5 (4.6%) of the probiotic and placebo group participants, respectively, odds ratio 1.62 (95% CI 0.51-5.10), P = 0.57. There were no serious, or probiotic-associated adverse events. CONCLUSION: Early and sustained untargeted administration of probiotic therapy with Lactobacillus plantarum 299v to adult patients admitted to the ICU is safe, but not associated with improved patient outcomes.

Management of Australian Patients with Severe Traumatic Brain Injury: Are Potentially Harmful Treatments Still Used?

Clinical trials have shown that intravenous albumin and decompressive craniectomy to treat early refractory intracranial hypertension can cause harm in patients with severe traumatic brain injury (TBI). The extent to which these treatments remain in use is unknown. We conducted a multi-center retrospective cohort study of adult patients with severe TBI admitted to five neurotrauma centers across Australia between April 2013 and March 2015. Patients were identified from local trauma and intensive care unit (ICU) registries and followed until hospital discharge. Main outcome measures were the administration of intravenous albumin, and decompressive craniectomy for intracranial hypertension. Analyses were predominantly descriptive. There were 303 patients with severe TBI, of whom a minority received albumin (6.9%) or underwent early decompressive craniectomy for treatment of refractory intracranial hypertension complicating diffuse TBI (2.3%). The median (intequartile range [IQR]) age was 35 (24, 58), and most injuries were caused by road traffic accidents (57.4%) or falls (25.1%). Overall, 34.3% of patients died while in the hospital and the remainder were discharged to rehabilitation (44.6%), other health care facilities (4.6%), or home (16.5%). There were no patient characteristics significantly associated with use of albumin or craniectomy. Intravenous albumin and craniectomy for treatment of intracranial hypertension were used infrequently in Australian neurotrauma centers, indicating alignment between best available evidence and practice.

Study protocol for the safety and efficacy of probiotic therapy on days alive and out of hospital in adult ICU patients: the multicentre, randomised, placebo-controlled Restoration Of gut microflora in Critical Illness Trial (ROCIT).

INTRODUCTION: The effect of early and sustained administration of daily probiotic therapy on patients admitted to the intensive care unit (ICU) remains uncertain. METHODS AND ANALYSIS: The Restoration Of gut microflora in Critical Illness Trial (ROCIT) study is a multicentre, randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 220 patients in five ICUs. Adult patients who are within 48 hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained Lactobacillus plantarum 299v probiotic therapy in addition to usual care or placebo in addition to usual care. The primary endpoint is days alive and out of hospital to day 60. ETHICS AND DISSEMINATION: ROCIT has been approved by the South Metropolitan Health Service Human Research Ethics Committee (ref: RGS00000004) and the St John of God Health Care Human Research Ethics Committee (ref: 1183). The trial results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ANZCTR12617000783325); Pre-results.

Internet health information use by surrogate decision makers of patients admitted to the intensive care unit: a multicentre survey.

OBJECTIVES: To investigate the use, understanding, trust and influence of the internet and other sources of health information used by the next of kin (NOK) of patients admitted to the intensive care unit (ICU). DESIGN: Multicentre structured survey. SETTING: The ICUs of 13 public and private Australian hospitals. PARTICIPANTS: NOK who self-identified as the primary surrogate decision maker for a patient admitted to the ICU. MAIN OUTCOME MEASURES: The frequency, understanding, trust and influence of online sources of health information, and the quality of health websites visited using the Health on the Net Foundation Code of Conduct (HONcode) for medical and health websites. RESULTS: There were 473 survey responses. The median ICU admission days and number of ICU visits by the NOK at the time of completing the survey was 3 (IQR, 2-6 days) and 4 (IQR, 2-7), respectively. The most commonly reported sources of health information used very frequently were the ICU nurse (55.6%), ICU doctor (38.7%), family (23.3%), hospital doctor (21.4%), and the internet (11.3%). Compared with the 243 NOK (51.6%) not using the internet, NOK using the internet were less likely to report complete understanding (odds ratio [OR], 0.57; 95% CI, 0.38-0.88), trust (OR, 0.34; 95% CI, 0.19-0.59), or influence (OR, 0.58; 95% CI, 0.38-0.88) associated with the ICU doctor. Overall, the quality of the 40 different reported websites accessed was moderately high. CONCLUSIONS: A substantial proportion of ICU NOK report using the internet as a source of health information. Internet use is associated with lower reported understanding, trust and influence of the ICU doctor.