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Background: Use of a lower haemoglobin (Hb) threshold to guide red blood cell (RBC) transfusion is now generally recommended in critically ill patients, but uncertainty remains regarding the optimal Hb threshold for RBC transfusion in patients of different ages.Methods: We conducted a post-hoc analysis of 998 patients with septic shock and anaemia randomised to RBC transfusion at a Hb threshold of 7 g/dl [4.3 mmol/l] vs 9 g/dl [5.6 mmol/l] in the Transfusion Requirements in Septic Shock (TRISS) trial. We assessed if there were heterogeneous effects between the allocated Hb threshold and patient age categorised and on the continuous scale. The primary outcome was 1-year mortality; the secondary outcome was 90-day mortality. Both outcomes were analysed using logistic regression models and in sensitivity analyses with additional adjusting for site of enrolment, presence of haematological malignancy and the Sequential Organ Failure Assessment (SOFA) score. The secondary analyses were Kaplan-Meier curves with corresponding log-rank tests.Results: We found no heterogeneity between patient age and the allocated Hb thresholds for RBC transfusion for 1-year mortality or 90-day mortality in the primary analyses. The sensitivity analyses suggested heterogeneity between age groups regarding 90-day mortality, however, this was not consistent for 1-year mortality or when assessing age on the continuous scale.Conclusion: In this post-hoc study of ICU patients with septic shock, we found no reliable heterogeneous effects of transfusion at a Hb threshold of 7 vs 9 g/dl according to patient age on mortality. However, due to low power, this study should only be considered as hypothesis generating. [ABSTRACT FROM AUTHOR]

Background: Red blood cell (RBC) transfusion is common in the intensive care unit (ICU). Recent trials have shown that a restrictive transfusion strategy is safe in most patients, and recent guidelines recommend such a strategy in most ICU patients. It is unknown if this has translated into a change in clinical practice.Methods: We conducted a population-based register study of RBC transfusions in ICUs in the Danish Capital Region between 1st of January 2011 and 31st of December 2016 by linking data from the regional blood bank and the Danish Intensive Care Database. We used crude data and run- and control-charts to analyse changes in the number of RBC transfusions.Results: We included 27 835 ICU admissions of which 6936 received 40 889 RBC units. The crude use was 36.2 RBC units per one-hundred patient bed-days in 2011 vs 29.8 in 2016. The run-chart analysis did not confirm a change in the total use of RBC units in all ICUs combined, and we observed no change in the proportion of transfused patients or in the use of RBCs among transfused patients. Sensitivity analyses showed decreased use of RBC units in two general ICUs, and a reduced use of RBC units among medical ICU patients.Conclusions: In this population-based register study, we did not with certainty observe changes over time in the use of RBC transfusions in all patients in all ICUs in the Danish Capital Region. A reduction in RBC use may have occurred in some general ICUs and in medical ICU patients. [ABSTRACT FROM AUTHOR]

Background: Current evidence indicates that it is safe to use a lower haemoglobin (Hb) threshold for red blood cell (RBC) transfusion as compared to a higher Hb-threshold. However, the recent Transfusion Requirements in Cardiac Surgery (TRICS-3) trial reported a significant interaction between patient age and the effect of lower vs higher Hb-thresholds for RBC transfusion. The interaction between patient age and transfusion strategy appears to differ between trials.Methods: This is the protocol and statistical analysis plan for a post hoc analysis of the Transfusion Requirements in Septic Shock (TRISS) trial. We will assess the effect of a lower vs a higher Hb-threshold for RBC transfusion in patients of different ages with septic shock. The primary and secondary outcomes are 1-year mortality and 90-day mortality respectively. We will assess age divided into six age groups and as a continuous variable and present baseline characteristics and odds ratios derived from both simple and adjusted (for the Sequential Organ Failure Assessment score, haematological malignancy, age and trial site) logistic regression models and P-values for the test-of-interaction. Furthermore, we will compare outcomes according to Hb-threshold in each age group using Kaplan-Meier curves and log-rank tests.Discussion: The outlined study will make a detailed assessment of potential interaction of patient age with transfusion strategy in patients with septic shock. This may inform future trials on the benefits and harms of RBC transfusion. [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]