Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation.

BACKGROUND: Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear. METHODS: In this international, randomized trial, we assigned critically ill adults who were undergoing invasive ventilation to receive intravenous pantoprazole (at a dose of 40 mg daily) or matching placebo. The primary efficacy outcome was clinically important upper gastrointestinal bleeding in the intensive care unit (ICU) at 90 days, and the primary safety outcome was death from any cause at 90 days. Multiplicity-adjusted secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding. RESULTS: A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other secondary outcomes were similar in the two groups. CONCLUSIONS: Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.).

Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis.

BACKGROUND: During the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies. OBJECTIVE: To describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring. METHODS: REVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022. RESULTS: The Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted. CONCLUSION: Protocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted.

Continuous vs Intermittent ß-Lactam Antibiotic Infusions in Critically Ill Patients With Sepsis: The BLING III Randomized Clinical Trial.

Importance: Whether ß-lactam antibiotics administered by continuous compared with intermittent infusion reduces the risk of death in patients with sepsis is uncertain. Objective: To evaluate whether continuous vs intermittent infusion of a ß-lactam antibiotic (piperacillin-tazobactam or meropenem) results in decreased all-cause mortality at 90 days in critically ill patients with sepsis. Design, Setting, and Participants: An international, open-label, randomized clinical trial conducted in 104 intensive care units (ICUs) in Australia, Belgium, France, Malaysia, New Zealand, Sweden, and the United Kingdom. Recruitment occurred from March 26, 2018, to January 11, 2023, with follow-up completed on April 12, 2023. Participants were critically ill adults (≥18 years) treated with piperacillin-tazobactam or meropenem for sepsis. Intervention: Eligible patients were randomized to receive an equivalent 24-hour dose of a ß-lactam antibiotic by either continuous (n = 3498) or intermittent (n = 3533) infusion for a clinician-determined duration of treatment or until ICU discharge, whichever occurred first. Main Outcomes and Measures: The primary outcome was all-cause mortality within 90 days after randomization. Secondary outcomes were clinical cure up to 14 days after randomization; new acquisition, colonization, or infection with a multiresistant organism or Clostridioides difficile infection up to 14 days after randomization; ICU mortality; and in-hospital mortality. Results: Among 7202 randomized participants, 7031 (mean [SD] age, 59 [16] years; 2423 women [35%]) met consent requirements for inclusion in the primary analysis (97.6%). Within 90 days, 864 of 3474 patients (24.9%) assigned to receive continuous infusion had died compared with 939 of 3507 (26.8%) assigned intermittent infusion (absolute difference, -1.9% [95% CI, -4.9% to 1.1%]; odds ratio, 0.91 [95% CI, 0.81 to 1.01]; P = .08). Clinical cure was higher in the continuous vs intermittent infusion group (1930/3467 [55.7%] and 1744/3491 [50.0%], respectively; absolute difference, 5.7% [95% CI, 2.4% to 9.1%]). Other secondary outcomes were not statistically different. Conclusions and Relevance: The observed difference in 90-day mortality between continuous vs intermittent infusions of ß-lactam antibiotics did not meet statistical significance in the primary analysis. However, the confidence interval around the effect estimate includes the possibility of both no important effect and a clinically important benefit in the use of continuous infusions in this group of patients. Trial Registration: ClinicalTrials.gov Identifier: NCT03213990.

How often are infusion sets for central venous catheters changed in Australian and New Zealand Intensive Care Units? A point prevalence survey.

BACKGROUND: Infusion sets (comprising the tubing, measuring burettes, fluid containers, transducers) that are connected to invasive vascular devices are changed on a regular basis in an effort to reduce bacterial colonisation and bloodstream infection. There is a balance between reducing infection and creating unnecessary waste. Current evidence suggests that for central venous catheters (CVCs), changing infusion sets at 7 days does not increase infection risks. OBJECTIVES: The objective of this study was to describe the current unit guidelines in Australian and New Zealand intensive care units (ICUs) for changing infusion sets for CVCs. METHODS: prospective cross-sectional point prevalence study, as a part of the 2021 Australian and New Zealand Intensive Care Society Point Prevalence Program. PARTICIPANTS: Australia and New Zealand (ANZ) adult ICUs and their patients on the day of the study. RESULTS: Data were collected from 51 ICUs across ANZ. One-third of these (16/49) ICUs had a guideline that specified a 7-day replacement period, with the rest having a more frequent replacement period. CONCLUSION: Most ICUs participating in this survey had policies to change their CVC infusion tubing in 3-4 days, and recent high-level evidence supports an update to extend this to 7 days. There remains work to be done to spread this evidence to ANZ ICUs and improve environmental sustainability initiatives.

Communication functions of adult patients admitted to intensive care: A multicentre, binational point prevalence study.

BACKGROUND: Patient communication is profoundly impacted during the intensive care unit (ICU) stay. While the impacts of altered communication are recognised, there is a paucity of data on the prevalence of communication attempts as well as modes utilised by patients and unit practices to manage communication function. OBJECTIVE: The objectives of this study were to describe the prevalence and characteristics of observed communication attempts (nonverbal, verbal, and use of the staff call bell) in adult ICU patients and report on unit-level practices on communication management. METHODS: A prospective, binational, cross-sectional point-prevalence study was conducted across 44 Australia and New Zealand adult ICUs. Data on communication attempts, modes, ICU-level guidelines, training, and resources were collected in June 2019. RESULTS: Across 44 ICUs, 470 of 623 (75%) participants, including ventilated and nonventilated patients, were attempting to communicate on the study day. Of those invasively ventilated via an endotracheal tube for the entire study day, 42 of 172 (24%) were attempting to communicate and 39 of 45 (87%) patients with a tracheostomy were attempting to communicate. Across the cohort, the primary mode of communication was verbal communication, with 395 of 470 (84%) patients using speech; of those 371 of 395 (94%) spoke English and 24 of 395 (6%) spoke a language other than English. Participants attempting to communicate on the study day had a shorter length of stay (LOS), a mean difference of 3.8 days (95% confidence interval: 0.2; 5.1) shorter LOS in the ICU than those not attempting to communicate, and a mean difference 7.9 days (95% confidence interval: 3.1; 12.6) shorter LOS in hospital overall. Unit-level practices and supports were collected. Six of 44 (14%) ICUs had a protocol for communication management, training was available in 11 of 44 (25%) ICUs, and communication resources were available in 37 of 44 (84%) ICUs. CONCLUSION: Three-quarters of patients admitted to the ICU were attempting to communicate on the study day, with multiple methods used to support verbal and nonverbal communication regardless of ventilation status. Guidance and training were absent from the majority of ICUs, indicating a need for development and implementation of policies, training, and resources.

Dysphagia in adult intensive care patients: Results of a prospective, multicentre binational point prevalence study.

BACKGROUND: Dysphagia occurs in intensive care unit (ICU) patients. However, there is a lack of epidemiological data on the prevalence of dysphagia in adult ICU patients. OBJECTIVES: The objective of this study was to describe the prevalence of dysphagia in nonintubated adult patients in the ICU. METHODS: A prospective, multicentre, binational, cross-sectional point prevalence study was conducted in 44 adult ICUs in Australia and New Zealand. Data were collected in June 2019 on documentation of dysphagia, oral intake, and ICU guidelines and training. Descriptive statistics were used to report demographic, admission, and swallowing data. Continuous variables are reported as means and standard deviations (SDs). Precisions of estimates were reported as 95% confidence intervals (CIs). RESULTS: Of the 451 eligible participants, 36 (7.9%) were documented as having dysphagia on the study day. In the dysphagia cohort, the mean age was 60.3 years (SD: 16.37) vs 59.6 years (SD: 17.1) and almost two-thirds were female (61.1% vs 40.1%). The most common admission source for those patients with dysphagia were from the emergency department (14/36, 38.9%), and seven of 36 (19.4%) had a primary diagnosis of trauma (odds ratio: 3.10, 95% CI 1.25 - 7.66). There were no statistical differences in Acute Physiology and Chronic Health Evaluation (APACHE II) scores between those with and without a dysphagia diagnosis. Patients with dysphagia were more likely to have a lower mean body weight of 73.3 kg vs 82.1 kg than patients not documented as having dysphagia (95% CI of mean difference: 0.43 to 17.07) and require respiratory support (odds ratio: 2.12, 95% 1.06 to 4.25). The majority of patients with dysphagia were prescribed modified food and fluids in the ICU. Less than half of ICUs surveyed reported unit-level guidelines, resources, or training for management of dysphagia. CONCLUSIONS: The prevalence of documented dysphagia in adult ICU nonintubated patients was 7.9%. There were a higher proportion of females with dysphagia than previously reported. Approximately two-thirds of patients with dysphagia were prescribed oral intake, and the majority were receiving texture-modified food and fluids. Dysphagia management protocols, resources, and training are lacking across Australian and New Zealand ICUs.

Prevalence of pressure injuries and the management of support surfaces (mattresses) in adult intensive care patients: A multicentre point prevalence study in Australia and New Zealand.

BACKGROUND: Pressure injuries (PIs) are a patient safety issue that impact patient outcomes. Intensive care unit (ICU) patients are at high risk of PIs. OBJECTIVES: To report the prevalence and classification of documented PIs in adult ICU patients, the use of pressure injury risk assessment tools, and support surface management as a part of the prevention of PIs. METHODS: This was a prospective, single-day, multicentre, cross-sectional study of patients aged ≥ 16 years admitted to adult ICUs in Australia and New Zealand (ANZ), August 2016 as part of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG) Point Prevalence Program. FINDINGS: Data were collected on 671 patients (58% male) in 47 ICUs. The mean [standard deviation] age and weight were 60.2 years [17.2 years] and 82.1 kg [29.7 kg], respectively, with a severity of illness score (Acute Physiology and Chronic Health Evaluation [APACHE] II) of 18.2 [8.4]. PIs were reported in 10% (70/671) of patients. Patients with a PI had a mean APACHE II score of 22.5 [standard deviation; 7.7], and 57.1% (40/70) met the criteria for sepsis on the study day. There were 107 PIs documented on the study day (N = 107) in the 70 patients with nearly half of PIs present on ICU admission (46.7%; 50/107). The sacrum was the most common location for PIs (28.9%; 31/107) and then the heels (15.9%; 17/107). All units routinely use a risk of PI assessment tool and were cared for on an active or reactive support surface. Patients with a PI were more often moved to an active support surface. CONCLUSIONS: The prevalence rate was reported at 10% for PIs for adult intensive care patients on the study day. More than half of the patients with a PI had signs of sepsis on the study day and a higher severity of illness, and more were cared for on active support surfaces. Most PIs were located at the sacrum and then the heels. All clinical sites routinely used a PI risk assessment tool.

Device-related pressure injuries in adult intensive care unit patients: An Australian and New Zealand point prevalence study.

BACKGROUND: Device-related pressure injuries (DRPIs) are an ongoing iatrogenic problem evident in intensive care unit (ICU) settings. Critically ill patients are at high risk of developing pressure injuries caused by devices. OBJECTIVE: The aim of the study was to determine the prevalence of DRPI in critically ill patients in intensive care and the location, stage, and attributable device of DRPI and describe the products and processes of care used to prevent these injuries. METHODS: This was a prospective, multicentre, cross-sectional point prevalence study of patients aged more than 16 years in Australian and New Zealand ICUs. The study was part of the Australian and New Zealand Intensive Care Society Clinical Trials Group Point Prevalence Program coordinated by The George Institute for Global Health. MAIN OUTCOME MEASURE: Identification of DRPI on the study day was the main outcome measure. RESULTS: Of the 624 patients included from 44 participating ICUs, 27 were found to have 35 identified DRPIs, giving a point prevalence DRPI rate of 4.3% (27/624). Study patients had a mean age of 59 years, and 60.3% were men. Patients with DRPI compared with patients without DRPI were significantly heavier (median: 92 kg versus 80 kg, respectively, p = 0.027), were less likely to survive the ICU (63.0% versus 85.9%, respectively, p = 0.015), had higher Acute Physiology and Chronic Health Evaluation II scores at admission to the ICU (median: 20 versus 16, respectively, p = 0.001), received mechanical ventilation more often (88.9% versus 43.5%, respectively, p < 0.001), and were more frequently diagnosed with respiratory conditions (37.0% versus 18.6%, respectively, p = 0.022). Processes of care activities were surveyed in 42 ICUs. Most DRPIs were attributed to endotracheal tubes and other respiratory devices. Forty-two ICUs reported processes of care to prevent DRPI, and just more than half of the participating sites (54.8%, 23/44) reported a dedicated ICU-based protocol for prevention of DRPI. CONCLUSION: DRPIs pose a burden on patients in the ICU. Our study showed a DRPI prevalence comparable with other studies. Prevention strategies targeting DRPI should be included in ICU-specific pressure injury prevention guidelines or protocols.

Knowledge, attitudes, beliefs and behaviour intentions for three bowel management practices in intensive care: effects of a targeted protocol implementation for nursing and medical staff.

BACKGROUND: Bowel management protocols have the potential to minimize complications for critically ill patients. Targeted implementation can increase the uptake of protocols by clinicians into practice. The theory of planned behaviour offers a framework in which to investigate clinicians' intention to perform the behaviour of interest. This study aimed to evaluate the effect of implementing a bowel management protocol on intensive care nursing and medical staffs' knowledge, attitude, subjective norms, perceived behavioural control, behaviour intentions, role perceptions and past behaviours in relation to three bowel management practices. METHODS: A descriptive before and after survey using a self-administered questionnaire sent to nursing and medical staff working within three intensive care units before and after implementation of our bowel management protocol (pre: May - June 2008; post: Feb - May 2009). RESULTS: Participants had significantly higher knowledge scores post-implementation of our protocol (pre mean score 17.6; post mean score 19.3; p = 0.004). Post-implementation there was a significant increase in: self-reported past behaviour (pre mean score 5.38; post mean score 7.11; p = 0.002) and subjective norms scores (pre mean score 3.62; post mean score 4.18; p = 0.016) for bowel assessment; and behaviour intention (pre mean score 5.22; post mean score 5.65; p = 0.048) for administration of enema. CONCLUSION: This evaluation, informed by the theory of planned behaviour, has provided useful insights into factors that influence clinician intentions to perform evidence-based bowel management practices in intensive care. Addressing factors such as knowledge, attitudes and beliefs can assist in targeting implementation strategies to positively affect clinician behaviour change. Despite an increase in clinicians' knowledge scores, our implementation strategy did not, however, significantly change clinician behaviour intentions for all three bowel management practices. Further research is required to explore the influence of opinion leaders and organizational culture on clinicians' behaviour intentions related to bowel management for intensive care patients.

Evaluation of the implementation of a bowel management protocol in intensive care: effect on clinician practices and patient outcomes.

AIMS AND OBJECTIVES: To evaluate the effect of a multifaceted implementation of a bowel management protocol on outcomes for intensive care patients, in particular the incidence of constipation and diarrhoea, and on clinicians' bowel management practices. BACKGROUND: Complications associated with poor bowel management for critically ill patients result in adverse outcomes. Implementation of protocols requires strategies proven to change clinician behaviour. DESIGN: Before and after study. METHODS: Our bowel management protocol was implemented using three evidence-based elements: education sessions, printed educational materials in the form of a fact sheet and reminders. We retrospectively collected data from patients' medical records admitted at two time points within three Sydney metropolitan intensive care units (preimplementation, n = 101; postimplementation, n = 107). RESULTS: No significant difference was found in the incidence of constipation and diarrhoea pre and postimplementation of the protocol. Seventy-two per cent (n = 73) of patients preimplementation and 70% (n = 75) of patients postimplementation experienced one or more episodes of constipation (bowels not open for 72 hours or greater), and 16% (n = 16) of patients preimplementation and 20% (n = 21) of patients postimplementation experienced one or more episodes of diarrhoea. There was a slight nonsignificant increase in bowel assessment on admission by medical officers postimplementation (pre, 47%, n = 48; post, 60%, n = 64). CONCLUSION: Targeted multifaceted implementation of a bowel management protocol did not have an impact on the incidence of constipation or diarrhoea for intensive care patients or on clinician practices. The lack of impact on patient outcomes may be due to clinicians' nonadherence to our bowel management protocol. Reasons clinicians' practices did not change may include the influences of clinical decision-making on behaviour. RELEVANCE TO CLINICAL PRACTICE: This study highlights difficulties inherent in changing clinician behaviour and practices to improve patient outcomes despite using an evidence-based multifaceted implementation strategy. Further research is required to ascertain the most effective implementation strategies.

Intensive care utilisation after elective surgery in Australia and New Zealand: A point prevalence study.

Objective: We aimed to describe the characteristics, outcomes and resource utilisation of patients being cared for in an ICU after undergoing elective surgery in Australia and New Zealand (ANZ). Methods: This was a point prevalence study involving 51 adult ICUs in ANZ in June 2021. Patients met inclusion criteria if they were being treated in a participating ICU on he study dates. Patients were categorised according to whether they had undergone elective surgery, admitted directly from theatre or unplanned from the ward. Descriptive and comparative analysis was performed according to the source of ICU admission. Resource utilisation was measured by Length of stay, organ support and occupied bed days. Results: 712 patients met inclusion criteria, with 172 (24%) have undergone elective surgery. Of these, 136 (19%) were admitted directly to the ICU and 36 (5.1%) were an unplanned admission from the ward. Elective surgical patients occupied 15.8% of the total ICU patient bed days, of which 44.3% were following unplanned admissions. Elective surgical patients who were an unplanned admission from the ward, compared to those admitted directly from theatre, had a higher severity of illness (AP2 17 vs 13, p<0.01), require respiratory or vasopressor support (75% vs 44%, p<0.01) and hospital mortality (16.7% vs 2.2%, p < 0.01). Conclusions: ICU resource utilisation of patients who have undergone elective surgery is substantial. Those patients admitted directly from theatre have good outcomes and low resource utilisation. Patient admitted unplanned from the ward, although fewer, were sicker, more resource intensive and had significantly worse outcomes.

Early sepsis in Australia and New Zealand: A point-prevalence study of haemodynamic resuscitation practices.

OBJECTIVE: Optimal resuscitation of sepsis-induced hypotension is uncertain, particularly the role of restrictive fluid strategies, leading to variability in usual practice. The objective of this study is to understand resuscitation practices in patients presenting to ED with early sepsis. METHODS: Design, participants and setting: Prospective, observational, multicentre, single-day, point-prevalence study enrolling adult patients present in 51 Australian and New Zealand ICUs at 10.00 hours, 8 June 2021. MAIN OUTCOME MEASURES: Site-level data on sepsis policies and patient-level demographic data, presence of sepsis and fluid and vasopressor administration in the first 24 h post-ED presentation. RESULTS: A total of 722 patients were enrolled. ED was the ICU admission source for 222 of 722 patients (31.2%) and 78 of 222 patients (35%) met the criteria for sepsis within 24 h of ED presentation. Median age of the sepsis cohort was 61 (48-72) years, 58% were male and respiratory infection was the commonest cause (53.8%). The sepsis cohort had a higher severity of illness than the non-sepsis cohort (144/222 patients) and chronic immunocompromise was more common. Of 78 sepsis patients, 55 (71%) received ≥1 fluid boluses with 500 and 1000 mL boluses equally common (both 49%). In the first 24 h, 2335 (1409-3125) mL (25.3 [13.2-42.9] mL/kg) was administered. Vasopressors were administered in 53 of 78 patients (68%) and for 25 patients (47%) administration was peripheral. CONCLUSIONS: ICU patients presenting to the ED with sepsis receive less fluids than current international recommendations and peripheral vasopressor administration is common. This finding supports the conduct of clinical trials evaluating optimal fluid dose and vasopressor timing for early sepsis-induced hypotension.

How much do we throw away in the intensive care unit? An observational point prevalence study of Australian and New Zealand ICUs.

Objective: During the current COVID pandemic, waste generation has been more evident with increased use of single use masks, gowns and other personal protective equipment. We aimed to understand the scale of waste generation, recycling rates and participation in Australian and New Zealand (ANZ) ICUs. Design: This is a prospective cross-sectional point prevalence study, as part of the 2021 ANZICS Point Prevalence Program. Specific questions related to waste and sustainability practices were asked at the site and patient level. Setting and participants: ANZ adult ICUs and their patients on the day of the study. Main outcome measures: Amount of single use items disposed of per shift, as well as the engagement of the site with sustainability and recycling practices. Results: In total, 712 patients (median number of patients per ICU = 17, IQR 11-30) from 51 ICUs across ANZ were included in our study; 55% of hospitals had a sustainability officer, and recycling paper (86%) and plastics (65%) were frequent, but metal recycling was limited (27%). Per patient bed space per 12-h shift there was recycling of less than 40% paper, glass, intravenous fluid bags, medication cups and metal instruments. A median of 10 gowns (IQR 3-19.5), 10 syringes (4.5-18) and gloves 30 (18-49) were disposed of per bed space, per 12-h shift. These numbers increased significantly when comparing patients with and without infection control precautions in place. Conclusions: In ANZ ICUs, we found utilisation of common ICU consumables to be high and associated with low recycling rates. Interventions to abate resource utilisation and augment recycling are required to improve environmental sustainability in intensive care units.

Transfusion practices in intensive care units: An Australian and New Zealand point prevalence study.

Objective: To describe current transfusion practices in intensive care units (ICUs) in Australia and New Zealand, compare them against national guidelines, and describe how viscoelastic haemostatic assays (VHAs) are used in guiding transfusion decisions. Design setting and participants: Prospective, multicentre, binational point-prevalence study. All adult patients admitted to participating ICUs on a single day in 2021. Main outcome measures: Transfusion types, amounts, clinical reasons, and triggers; use of anti-platelet medications, anti-coagulation, and VHA. Results: Of 712 adult patients in 51 ICUs, 71 (10%) patients received a transfusion during the 24hr period of observation. Compared to patients not transfused, these patients had higher Acute Physiology and Chronic Health Evaluation II scores (19 versus 17, p = 0.02), a greater proportion were mechanically ventilated (49.3% versus 37.3%, p < 0.05), and more had systemic inflammatory response syndrome (70.4% versus 51.3%, p < 0.01). Overall, 63 (8.8%) patients received red blood cell (RBC) transfusions, 10 (1.4%) patients received platelet transfusions, 6 (0.8%) patients received fresh frozen plasma (FFP), and 5 (0.7%) patients received cryoprecipitate. VHA was available in 42 (82.4%) sites but only used in 6.6% of transfusion episodes when available. Alignment with guidelines was found for 98.6% of RBC transfusions, but only 61.6% for platelet, 28.6% for FFP, and 20% for cryoprecipitate transfusions. Conclusions: Non-RBC transfusion decisions are often not aligned with guidelines and VHA is commonly available but rarely used to guide transfusions. Better evidence to guide transfusions in ICUs is needed.

Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial.

BACKGROUND: Critically ill patients commonly receive proton pump inhibitors (PPIs) to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite widespread use in the intensive care unit (ICU), observational data suggest that PPIs may be associated with adverse outcomes in patients with COVID-19 infection. This preplanned study is nested within a large randomized trial evaluating pantoprazole versus placebo in invasively ventilated patients. The 3 objectives are as follows: (1) to describe the characteristics of patients with COVID-19 in terms of demographics, biomarkers, venous thromboembolism, tracheostomy incidence and timing, and other clinical outcomes; (2) to evaluate the impact of COVID-19 infection on clinically important GI bleeding, 90-day mortality, and other outcomes compared to a propensity-matched non-infected cohort; and (3) to explore whether pantoprazole has a differential treatment effect on clinically important GI bleeding, 90-day mortality, and other outcomes in patients with and without COVID-19 infection. METHODS: The ongoing trial Re-EValuating the Inhibition of Stress Erosions (REVISE) compares pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important GI bleeding and the primary safety outcome of 90-day mortality. The protocol described in this report is for a substudy focused on patients with COVID-19 infection that was not in the original pre-pandemic trial protocol. We developed a one-page case report form to characterize these patients including data related to biomarkers, venous thromboembolism, COVID-19 therapies, tracheostomy incidence and timing, duration of mechanical ventilation, and ICU and hospital stay. Our analysis will describe the trajectory of patients with COVID-19 infection, a propensity-matched analysis of infected and non-infected patients, and an extended subgroup analysis comparing the effect of PPI among patients with and without COVID-19 infection. DISCUSSION: Prophylactic acid suppression in invasively ventilated critically ill patients with COVID-19 infection has unknown consequences. The results of these investigations will inform practice, guidelines, and future research. TRIAL REGISTRATION: REVISE Trial [NCT03374800 December 15, 2017], COVID-19 Cohort Study [NCT05715567 February 8, 2023].

REVISE: re-evaluating the inhibition of stress erosions in the ICU-statistical analysis plan for a randomized trial.

BACKGROUND: The REVISE (Re-Evaluating the Inhibition of Stress Erosions in the ICU) trial will evaluate the impact of the proton pump inhibitor pantoprazole compared to placebo in invasively ventilated critically ill patients. OBJECTIVE: To outline the statistical analysis plan for the REVISE trial. METHODS: REVISE is a randomized clinical trial ongoing in intensive care units (ICUs) internationally. Patients ≥ 18 years old, receiving invasive mechanical ventilation, and expected to remain ventilated beyond the calendar day after randomization are allocated to either 40 mg pantoprazole intravenously or placebo while mechanically ventilated. RESULTS: The primary efficacy outcome is clinically important upper GI bleeding; the primary safety outcome is 90-day mortality. Secondary outcomes are ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine concentration, and duration of mechanical ventilation, ICU, and hospital length of stay. Following an interim analysis of results from 2400 patients (50% of 4800 target sample size), the data monitoring committee recommended continuing enrolment. CONCLUSIONS: This statistical analysis plan outlines the statistical analyses of all outcomes, sensitivity analyses, and subgroup analyses. REVISE will inform clinical practice and guidelines worldwide. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT03374800. November 21, 2017.

Corrigendum to "Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent ß-lactam antibiotic infusion in critically ill patients with sepsis" [Crit Care Resusc 23(3) (2021) 273-284].

[This corrects the article DOI: 10.51893/2021.3.oa4.].

REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol.

INTRODUCTION: The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE. METHODS AND ANALYSIS: REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial. ETHICS AND DISSEMINATION: All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to - Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide. TRIAL REGISTRATION NUMBER: NCT03374800.

Violence in intensive care: a point prevalence study.

Introduction: Violence in the intensive care unit (ICU) is poorly characterised and its incidence is largely extrapolated from studies in the emergency department. Policy requirements vary between jurisdictions and have not been formally evaluated. Methods: A multisite, single-time point observational study was conducted across Australasian ICUs which focused on the incidence of violence in the previous 24 hours, the characteristics of patients displaying violent behaviour, the perceived contributors, and the management strategies implemented. Unit policies were surveyed across a range of domains relevant to violence management. Results: Data were available for 627 patients admitted to 44 ICUs on one of 2 days in June 2019. Four per cent (25/627) displayed at least one episode of violent behaviour in the previous 24 hours. Violent behaviour was more likely in individuals after a greater length of stay in hospital (incidence, 2%, 4% and 7% for day 0-2, 3-7 and > 7 days respectively; P = 0.01) and in the ICU (2%, 4% and 9% for day 0-2, 3-7 and > 7 of ICU stay respectively; P < 0.01). The most common perceived contributors to violence were confusion (64%), physical illness (40%), and psychiatric illness (34%). Management with chemical sedation (72%) and physical restraint (28%) was commonly required. Clinicians assessed an additional 53 patients (53/627, 9%) as at risk of displaying violence in the next 24 hours. Of the 44 participating ICUs, 30 (68%) had a documented violence procedure. Conclusion: Violence in the ICU was common and frequently required intervention. In this study, one-third of ICUs did not have formal violence procedures, and in those with violence procedures, considerable variation was observed.

Pain assessment and analgesic management in patients admitted to intensive care: an Australian and New Zealand point prevalence study.

Objective: To describe pain assessment and analgesic management practices in patients in intensive care units (ICUs) in Australia and New Zealand. Design, setting and participants: Prospective, observational, multicentre, single-day point prevalence study conducted in Australian and New Zealand ICUs. Observational data were recorded for all adult patients admitted to an ICU without a neurological, neurosurgical or postoperative cardiac diagnosis. Demographic characteristics and data on pain assessment and analgesic management for a 24-hour period were collected. Main outcome measures: Types of pain assessment tools used and frequency of their use, use of opioid analgesia, use of adjuvant analgesia, and differences in pain assessment and analgesic management between postoperative and non-operative patients. Results: From the 499 patients enrolled from 45 ICUs, pain assessment was performed at least every 4 hours in 56% of patients (277/499), most commonly with a numerical rating scale. Overall, 286 patients (57%) received an opioid on the study day. Of the 181 mechanically ventilated patients, 135 (75%) received an intravenous opioid, with the predominant opioid infusion being fentanyl. The median dose of opioid infusion for ventilated patients was 140 mg oral morphine equivalents. Of the 318 non-ventilated patients, 41 (13%) received patient-controlled analgesia and 76 (24%) received an oral opioid, with the predominant opioid being oxycodone. Paracetamol was administered to 63 ventilated patients (35%) and 164 non-ventilated patients (52%), while 2% of all patients (11/499) received a non-steroidal anti-inflammatory drug. Ketamine infusion and regional analgesia were used in 15 patients (3%) and 17 patients (3%), respectively. Antineuropathic agents (predominantly gabapentinoids) were used in 53 patients (11%). Conclusions: Although a majority of ICU patients were frequently assessed for pain with a validated pain assessment tool, cumulative daily doses of opioids were high, and the use of multimodal adjuvant analgesia was low. Our data on current pain assessment and analgesic management practices may inform further research in this area.