IMPORTANCE: Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The ...comparative effect of these drugs on mortality is unknown. OBJECTIVE: To compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis. DESIGN, SETTING, AND PARTICIPANTS: Cluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital. INTERVENTIONS: Two stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs). MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay. RESULTS: Among 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean SD age, 58 17.0 years; 9691 36.1% were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 95% CI, 1.00 to 1.10; absolute risk difference, 0.93 percentage points 95% CI, −0.01 to 1.88 percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 95% CI, 0.57 to 0.92; absolute risk difference, −0.51 percentage points 95% CI, −0.90 to −0.12 percentage points; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group. CONCLUSIONS AND RELEVANCE: Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12616000481471
ObjectiveTo characterise the self-isolating household units (bubbles) during the COVID-19 Alert Level 4 lockdown in New Zealand.Design, setting and participantsIn this cross-sectional study, an ...online survey was distributed to a convenience sample via Facebook advertising and the Medical Research Institute of New Zealand’s social media platforms and mailing list. Respondents were able to share a link to the survey via their own social media platforms and by email. Results were collected over 6 days during Alert Level 4 from respondents living in New Zealand, aged 16 years and over.Main outcomes measuresThe primary outcome was the mean size of a self-isolating household unit or bubble. Secondary outcomes included the mean number of households in each bubble, the proportion of bubbles containing essential workers and/or vulnerable people, and the mean number of times the home was left each week.Results14 876 surveys were included in the analysis. The mean (SD) bubble size was 3.58 (4.63) people, with mean (SD) number of households 1.26 (0.77). The proportion of bubbles containing one or more essential workers, or one or more vulnerable persons was 45.3% and 42.1%, respectively. The mean number of times individual bubble members left their home in the previous week was 12.9 (12.4). Bubbles that contained at least one vulnerable individual had fewer outings over the previous week compared with bubbles that did not contain a vulnerable person. The bubble sizes were similar by respondent ethnicity.ConclusionIn this New Zealand convenience sample, bubble sizes were small, mostly limited to one household, and a high proportion contained essential workers and/or vulnerable people. Understanding these characteristics from a country which achieved a low COVID-19 infection rate may help inform public health interventions during this and future pandemics.
Purpose
It is unknown whether protocols targeting systematic prevention and treatment of fever achieve lower mean body temperature than usual care in intensive care unit (ICU) patients. The objective ...of the
Randomised Evaluation of Active Control of temperature vs. ORdinary temperature management
trial was to confirm the feasibility of such a protocol with a view to conducting a larger trial.
Methods
We randomly assigned 184 adults without acute brain pathologies who had a fever in the previous 12 h, and were expected to be ventilated beyond the calendar day after recruitment, to systematic prevention and treatment of fever or usual care. The primary outcome was mean body temperature in the ICU within 7 days of randomisation. Secondary outcomes included in-hospital mortality, ICU-free days and survival time censored at hospital discharge.
Results
Compared with usual temperature management, active management significantly reduced mean temperature. In both groups, fever generally abated within 72 h. The mean temperature difference between groups was greatest in the first 48 h, when it was generally in the order of 0.5 °C. Overall, 23 of 89 patients assigned to active management (25.8%) and 23 of 89 patients assigned to usual management (25.8%) died in hospital (odds ratio 1.0, 95% CI 0.51–1.96,
P
= 1.0). There were no statistically significant differences between groups in ICU-free days or survival to day 90.
Conclusions
Active temperature management reduced body temperature compared with usual care; however, fever abated rapidly, even in patients assigned to usual care, and the magnitude of temperature separation was small.
Trial registration
Australian and New Zealand Clinical Trials Registry Number, ACTRN12616001285448
Objective To evaluate the effect of Plasma-Lyte® 148 (PL-148) compared with 0.9% saline (saline) on blood product use and postoperative bleeding in patients admitted to the intensive care unit (ICU) ...following cardiac surgery. Design A post-hoc subgroup analysis conducted within a multicenter, double-blind, cluster-randomized, double-crossover study (study 1) and a prospective, single-center nested-cohort study (study 2). Setting Tertiary care hospitals. Participants Adults admitted to ICU after cardiac surgery requiring crystalloid fluid therapy as part of the 0.9% Saline vs. PL-148 for ICU fluid Therapy (SPLIT) trial. Interventions Blinded saline or PL-148 for four alternating seven-week blocks. Measurements and Main Results 954 patients were included in study 1, 475 patients received PL-148 and 479 received saline. 128 of 475 patients (26.9%) in the PL-148 group received blood or a blood product compared with 94 of 479 patients (19.6%) in the saline group (OR 95% CI, 1.51 1.11-2.05; P=0.008). In study 2, 131 patients were allocated to PL-148 and 120 patients were allocated to saline. There were no differences between groups in chest drain output from the time of arrival in ICU until 12 hours postoperatively (geometric mean, 566mL for the PL-148 group vs. 547mL in the saline group, P=0.60). Conclusions Our findings do not support the hypothesis that using PL-148 for fluid therapy in ICU following cardiac surgery reduces transfusion requirements compared to saline. The significantly increased proportion of patients receiving blood or blood product with allocation to PL-148 compared to saline was unexpected and requires verification through further research.
Evaluates the effect of energy-dense vs routine enteral nutrition on day-90 mortality by ethnic group in critically ill adults. Tests the hypothesis that for day-90 mortality there would be a ...statistically significant interaction between ethnicity and treatment allocation. Reports the mortality of enrolled participants by ethnic group adjusted for treatment allocation and important baseline covariates. Source: National Library of New Zealand Te Puna Matauranga o Aotearoa, licensed by the Department of Internal Affairs for re-use under the Creative Commons Attribution 3.0 New Zealand Licence.
Background: The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ...ventilated in the intensive care unit (ICU) is uncertain.
Objective: To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study.
Design, setting and participants: Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019.
Main outcome measures: The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay.
Results and conclusions: The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.
Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTRN 12616000481471).
Background: 0.9% saline is the most commonly used intravenous (IV) fluid in the world. However, recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte ...148, the administration of 0.9% saline to intensive care unit patients might increase their risk of acute kidney injury (AKI). Objective: To describe the protocol for the 0.9% Saline v Plasma-Lyte 148 for ICU Fluid Therapy (SPLIT) study. Methods: This is a multicentre, cluster-randomised, double crossover feasibility study to be conducted in four New Zealand tertiary ICUs over a 28-week period and will enrol about 2300 participants. All ICU patients who need crystalloid IV fluid therapy (except those with established renal failure needing dialysis and those admitted to the ICU for palliative care) will be enrolled. Participating ICUs will be randomly assigned to 0.9% saline or Plasma-Lyte 148 as the routine crystalloid IV fluid, in a blinded fashion, in four alternating 7-week blocks. Main outcome measures: The primary outcome will be the proportion of patients who develop AKI in the ICU. Secondary outcomes will include the difference between the most recent serum creatinine level measured before study enrolment and the peak serum creatinine level in the ICU; use of renal replacement therapy; and ICU and inhospital mortality. All analyses will be conducted on an intention-to-treat basis. Results and conclusion: The SPLIT study started on 1 April 2014 and will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma- Lyte 148 as the routine IV fluid therapy in ICU patients.
Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallelgroup, concealed, blinded, randomised controlled trial comparing the effect of ...Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study.
Methods: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses.
Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.
Background: The balance of risks and benefits of conservative v standard care oxygen strategies for patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. Objective: To ...describe the study protocol and statistical analysis plan for the ICU randomised trial comparing two approaches to oxygen therapy (ICU-ROX). Design, setting and participants: Protocol for a multicentre, randomised, participant and outcome assessor-blinded, standard care-controlled, parallel-group, two-sided superiority trial to be conducted in up to 22 ICUs in Australia and New Zealand. 1000 adults who are mechanically ventilated in the ICU and expected to remain ventilated beyond the day after recruitment will be randomly assigned to conservative oxygen therapy or standard care in a 1:1 ratio. ICU-ROX began with an internal pilot phase in September 2015. It is anticipated that recruitment will be completed in 2018. Main outcome measures: The primary endpoint will be alive, ventilator-free days to Day 28. Secondary outcomes include 90- and 180-day all-cause mortality, survival time to 180 days, and quality of life and cognitive function at 180 days. All analyses will be conducted on an intentionto- treat basis. Results and conclusions: ICU-ROX will compare the effect of conservative v standard oxygen therapy in critically ill mechanically ventilated adults who are expected to be ventilated beyond the day after recruitment on ventilator free days to Day 28. Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTRN 12615000957594).
O2, do we know what to do? Young, Paul J.; Bagshaw, Sean M.; Bailey, Michael ...
Critical Care and Resuscitation/aCritical care and resuscitation,
12/2019, Letnik:
21, Številka:
4
Journal Article
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