Search

Background: Variation in usual practice in fluid trials assessing lower versus higher volumes may affect overall comparisons. To address this, we will evaluate the effects of heterogeneity in treatment intensity in the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care trial. This will reflect the effects of differences in site‐specific intensities of standard fluid treatment due to local practice preferences while considering participant characteristics. Methods: We will assess the effects of heterogeneity in treatment intensity across one primary (all‐cause mortality) and three secondary outcomes (serious adverse events or reactions, days alive without life support and days alive out of hospital) after 90 days. We will classify sites based on the site‐specific intensity of standard fluid treatment, defined as the mean differences in observed versus predicted intravenous fluid volumes in the first 24 h in the standard‐fluid group while accounting for differences in participant characteristics. Predictions will be made using a machine learning model including 22 baseline predictors using the extreme gradient boosting algorithm. Subsequently, sites will be grouped into fluid treatment intensity subgroups containing at least 100 participants each. Subgroups differences will be assessed using hierarchical Bayesian regression models with weakly informative priors. We will present the full posterior distributions of relative (risk ratios and ratios of means) and absolute differences (risk differences and mean differences) in each subgroup. Discussion: This study will provide data on the effects of heterogeneity in treatment intensity while accounting for patient characteristics in critically ill adult patients with septic shock. Registrations: The European Clinical Trials Database (EudraCT): 2018‐000404‐42, ClinicalTrials. gov: NCT03668236. [ABSTRACT FROM AUTHOR]

Background: Albumin administration is suggested in patients with sepsis and septic shock who have received large volumes of crystalloids. Given lack of firm evidence, clinical practice variation may exist. To address this, we investigated if patient characteristics or trial site were associated with albumin use in septic shock. Methods: We conducted a post‐hoc study of the CLASSIC international, randomised clinical trial of fluid volumes in septic shock. Associations between selected baseline variables and trial site with albumin use during ICU stay were assessed in Cox models considering death, ICU discharge, and loss‐to‐follow‐up as competing events. Baseline variables were first assessed individually, adjusted for treatment allocation (restrictive vs. standard IV fluid), and then adjusted for allocation and the other baseline variables. Site was assessed in a model adjusted for allocation and baseline variables. Results: We analysed 1541 of 1554 patients randomised in CLASSIC (99.2%). During ICU stay, 36.3% of patients in the restrictive‐fluid group and 52.6% in the standard‐fluid group received albumin. Gastrointestinal focus of infection and higher doses of norepinephrine were most strongly associated with albumin use (subgroup with highest quartile of norepinephrine doses, hazard ratio (HR) 2.58, 95% CI 1.89 to 3.53). HRs for associations between site and albumin use ranged from 0.11 (95% CI 0.05 to 0.26) to 1.70 (95% CI 1.06 to 2.74); test for overall effect of site: p <.001. Conclusions: In adults with septic shock, gastrointestinal focus of infection and higher doses of norepinephrine at baseline were associated with albumin use, which also varied substantially between sites. [ABSTRACT FROM AUTHOR]

Background: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre‐planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). Methods: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life‐support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. Results: The absolute difference in mortality was 0.2%‐points (95% credible interval: −5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%‐points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life‐support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%‐points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life‐support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. Conclusion: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life‐support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy. [ABSTRACT FROM AUTHOR]

The severe acute respiratory syndrome coronavirus 2 (COVID‐19) pandemic has placed an unprecedented challenge on healthcare systems across the globe. Rapid assessment of the cardiorespiratory function to monitor disease progression and guide treatment is essential. Therefore, we have designed the COVID‐US: a simplified cardiopulmonary ultrasound approach to use in suspected and confirmed COVID‐19 patients, to aid front‐line health workers in their decision‐making in a surge crisis. [ABSTRACT FROM AUTHOR]

Background: In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.Aim: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.Methods: In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.Discussion: With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock. [ABSTRACT FROM AUTHOR]

Introduction: Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock.Methods: CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population.Discussion: The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock. [ABSTRACT FROM AUTHOR]

Objective: To describe the recommended procedure and common ultrasonographic findings and present a framework for labelling, recording and reporting of images obtained during a focused lung ultrasound study. Background: Lung ultrasound is a widely utilised point‐of‐care investigation in acute care, providing valuable diagnostic information in patients with dyspnoea or haemodynamic instability. It has a number of recognised advantages and has been incorporated into a variety of clinical algorithms. Recommendations for performing lung ultrasound and description of common artefacts are readily available; however, there is a lack of a recognised framework for labelling and reporting a lung ultrasound study. Standardised recording, labelling and reporting are important clinically, while promoting consistency, quality assurance, teaching and research opportunities. Documenting lung ultrasound also has potential medico‐legal implications. Results: For focused lung ultrasound, an extended bilateral four‐quadrant approach is recommended. Acquired images and loops should be clearly labelled identifying left or right, anterior or lateral and inferior, superior or posterior locations. 2D loops should be of sufficient length to clearly demonstrate pleural sliding, complemented by M‐mode stills if required. Reports should provide information regarding the presence or absence of an intact pleural interface, the presence or absence and the size and nature of pleural collections as well as any parenchymal artefacts or consolidation, in all examined locations. It is important to use internationally accepted terminology to describe findings, and it is also recommended to conclude the report with a clear summary that can be interpreted by healthcare providers without specific training in lung ultrasound. [ABSTRACT FROM AUTHOR]

Critical care echocardiography (CCE) is commonly performed in many intensive care units across Australia and New Zealand (ANZ). The scope of practice ranges from Basic CCE through to Advanced CCE and includes the use of transthoracic echocardiography and transoesophageal echocardiography. Many training and qualification pathways exist with no standardisation of education goals. This document defines different levels of CCE expertise and recommends minimum training standards for each level of adult CCE in ANZ. Guidelines committee of College of Intensive Care Medicine's Ultrasound Special Interest Group held multiple face to face meetings, organised teleconferences, conducted a survey of the Fellows of the college and reviewed the international CCE training pathways prior to writing these guidelines. [ABSTRACT FROM AUTHOR]

Abstract: To study gas exchange in the filter during continuous venovenous hemodiafiltration (CVVHDF), an air-tight heated mixing chamber with adjustable CO2 supply was constructed and connected to a CVVHDF monitor. Bicarbonate-free crystalloid (Part 1) and packed red blood cell (Part 2) solutions were circulated at 150 ml · min-1. Gas exchange expressed as pre-postfilter difference in CO2 and O2 contents was measured at different CVVHDF settings and temperatures of circulating and dialysis solutions. Ultrafiltration was most efficacious for CO2 removal (at 1,000 ml · h-1 ultrafiltration CO2 losses reached 13% of prefilter CO2 content). Addition of dialysis (1,000 ml · h-1) increased CO2 loss to 17% and at maximal parameters (filtration 3,000 ml · h-1, dialysis 2,500 ml · h-1), the loss of CO2 amounted to 35% of prefilter content. Temperature changes of circulating and/or dialysis fluids had no significant impact on CO2 losses. The O2 exchange during CVVHDF was negligible. Currently used CVVHDF is only marginally effective in CO2 removal. Higher volume ultrafiltration combined with dialysis can be expected to reach clinical significance. [ABSTRACT FROM AUTHOR]

Introduction Methods Results Conclusions Use of albumin is suggested for some patients with shock, but preferences for its use may vary among intensive care unit (ICU) physicians.We conducted an international online survey of ICU physicians with 20 questions about their use of albumin and their opinion towards a randomised trial among adults with shock comparing the use versus no use of albumin.A total of 1248 respondents participated, with a mean response rate of 37%, ranging from 18% to 75% across 21 countries. Respondents mainly worked in mixed ICUs and 92% were specialists in intensive care medicine. The reported use of albumin in general shock varied as 18% reported ‘almost never’, 22% ‘rarely’, 34% ‘occasionally’, 22% ‘frequently’ and 4% ‘almost always’ using albumin. In septic shock, 19% reported ‘almost never’, 22% ‘rarely’, 29% ‘occasionally’, 22% ‘frequently’ and 7% ‘almost always’ using albumin. Physicians’ preferences were more consistent for haemorrhagic‐ and cardiogenic shock, with more than 45% reporting ‘almost never’ using albumin. While the reported use of albumin for other purposes than resuscitation was infrequent (40%–85% reported ‘almost never’ for five other indications), the most frequent other indications were low serum albumin levels and improvement of the efficacy of diuretics. Most respondents (93%) would randomise adult ICU patients with shock to a trial of albumin versus no albumin.In this international survey, the reported preferences for the use of albumin in adult ICU patients with shock varied considerably among surveyed ICU physicians. The support for a future randomised trial was high. [ABSTRACT FROM AUTHOR]

Background: Intravenous (IV) albumin is suggested for patients with septic shock who have received large amounts of IV crystalloids; a conditional recommendation based on moderate certainty of evidence. Clinical variation in the administration of IV albumin in septic shock may exist according to patient characteristics and location., Methods: This is a protocol and statistical analysis plan for a post-hoc secondary study of the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC) RCT of 1554 adult ICU patients with septic shock. We will assess if specific baseline characteristics or trial site are associated with the administration of IV albumin during ICU stay using Cox models with competing events. All models will be adjusted for the treatment allocation in CLASSIC (restrictive vs. standard IV fluid), and all analyses will consider competing events (death, ICU discharge and loss-to-follow-up). We will present results as hazard ratios with 95% confidence intervals and p-values for the associations of baseline characteristics or site with IV albumin administration. Between-group differences (interactions) will be assessed using p-values from likelihood ratio tests. All results will be considered exploratory only., Discussion: This secondary study of the CLASSIC RCT may yield important insight into potential practice variation in the administration of albumin in septic shock., (© 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)

Background: In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes., Aim: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial., Methods: In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function., Discussion: With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock., (© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)