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Background: Mortality prediction models are applied in the intensive care unit (ICU) to stratify patients into different risk categories and to facilitate benchmarking. To ensure that the correct prediction models are applied for these purposes, the best performing models must be identified. As a first step, we aimed to establish a systematic review of mortality prediction models in critically ill patients., Methods: Mortality prediction models were searched in four databases using the following criteria: developed for use in adult ICU patients in high-income countries, with mortality as primary or secondary outcome. Characteristics and performance measures of the models were summarized. Performance was presented in terms of discrimination, calibration and overall performance measures presented in the original publication., Results: In total, 43 mortality prediction models were included in the final analysis. In all, 15 models were only internally validated (35%), 13 externally (30%) and 10 (23%) were both internally and externally validated by the original researchers. Discrimination was assessed in 42 models (98%). Commonly used calibration measures were the Hosmer-Lemeshow test (60%) and the calibration plot (28%). Calibration was not assessed in 11 models (26%). Overall performance was assessed in the Brier score (19%) and the Nagelkerke's R 2 (4.7%)., Conclusions: Mortality prediction models have varying methodology, and validation and performance of individual models differ. External validation by the original researchers is often lacking and head-to-head comparisons are urgently needed to identify the best performing mortality prediction models for guiding clinical care and research in different settings and populations., (© 2019 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.)

Background: Acute Kidney Injury (AKI) in critically ill patients is associated with a markedly increased morbidity and mortality. The aim of this study was to establish the predictive value of clinical examination for AKI in critically ill patients., Methods: This was a sub-study of the SICS-I, a prospective observational cohort study of critically ill patients acutely admitted to the Intensive Care Unit (ICU). Clinical examination was performed within 24 hours of ICU admission. The occurrence of AKI was determined at day two and three after admission according to the KDIGO definition including serum creatinine and urine output. Multivariable regression modeling was used to assess the value of clinical examination for predicting AKI, adjusted for age, comorbidities and the use of vasopressors., Results: A total of 1003 of 1075 SICS-I patients (93%) were included in this sub-study. 414 of 1003 patients (41%) fulfilled the criteria for AKI. Increased heart rate (OR 1.12 per 10 beats per minute increase, 98.5% CI 1.04-1.22), subjectively cold extremities (OR 1.52, 98.5% CI 1.07-2.16) and a prolonged capillary refill time on the sternum (OR 1.89, 98.5% CI 1.01-3.55) were associated with AKI. This multivariable analysis yielded an area under the receiver-operating curve (AUROC) of 0.70 (98.5% CI 0.66-0.74). The model performed better when lactate was included (AUROC of 0.72, 95%CI 0.69-0.75), P = .04., Conclusion: Clinical examination findings were able to predict AKI with moderate accuracy in a large cohort of critically ill patients. Findings of clinical examination on ICU admission may trigger further efforts to help predict developing AKI., (© 2019 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)

Background: In the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial, 3291 adult ICU patients at risk for gastrointestinal (GI) bleeding were randomly allocated to intravenous pantoprazole 40 mg or placebo once daily in the ICU. No difference was observed between the groups in the primary outcome 90-day mortality or the secondary outcomes, except for clinically important gastrointestinal bleeding. However, heterogeneity of treatment effect (HTE) not detected by conventional subgroup analyses could be present., Methods: This is a protocol and statistical analysis plan for a secondary, post hoc, exploratory analysis of the SUP-ICU trial. We will explore HTE in one set of subgroups based on severity of illness (using the Simplified Acute Physiology Score [SAPS] II) and another set of subgroups based on the total number of risk factors for GI bleeding in each patient using Bayesian hierarchical models. We will summarise posterior probability distributions using medians and 95% credible intervals and present probabilities for different levels of benefit and harm of the intervention in each subgroup. Finally, we will assess if the treatment effect interacts with SAPS II and the number of risk factors separately on the continuous scale using marginal effects plots., Conclusions: The outlined post hoc analysis will explore whether HTE was present in the SUP-ICU trial and may help answer some of the remaining questions regarding the balance between benefits and harms of pantoprazole in ICU patients at risk of GI bleeding. CLINICALTRIALS., Gov Registration: NCT02467621., (© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Background: Dopamine has been used in patients with cardiac dysfunction for more than five decades. Yet, no systematic review has assessed the effects of dopamine in critically ill patients with cardiac dysfunction., Methods: This systematic review was conducted following The Cochrane Handbook for Systematic Reviews of Interventions. We searched for trials including patients with observed cardiac dysfunction published until 19 April 2018. Risk of bias was evaluated and Trial Sequential Analyses were conducted. The primary outcome was all-cause mortality at longest follow-up. Secondary outcomes were serious adverse events, myocardial infarction, arrhythmias, and renal replacement therapy. We used GRADE to assess the certainty of the evidence., Results: We identified 17 trials randomising 1218 participants. All trials were at high risk of bias and only one trial used placebo. Dopamine compared with any control treatment was not significantly associated with relative risk of mortality (60/457 [13%] vs 90/581 [15%]; RR 0.91; 95% confidence interval 0.68-1.21) or any other patient-centred outcomes. Trial Sequential Analyses of all outcomes showed that there was insufficient information to confirm or reject our anticipated intervention effects. There were also no statistically significant associations for any of the outcomes in subgroup analyses by type of comparator (inactive compared to potentially active), dopamine dose (low compared to moderate dose), or setting (cardiac surgery compared to heart failure)., Conclusion: Evidence for dopamine in critically ill patients with cardiac dysfunction is sparse, of low quality, and inconclusive. The use of dopamine for cardiac dysfunction can neither be recommended nor refuted., (© 2018 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)

Background: Perioperative goal-directed therapy aims to optimise haemodynamics by titrating fluids, vasopressors and/or inotropes to predefined haemodynamic targets. Perioperative goal-directed therapy is a complex intervention composed of several independent component interventions. Trials on perioperative goal-directed therapy show conflicting results. We aimed to conduct a systematic review and meta-analysis to investigate the benefits and harms of perioperative goal-directed therapy., Methods: PubMED, EMBASE, Web of Science and Cochrane Library were searched. Trials were included if they had a perioperative goal-directed therapy protocol. The primary outcome was all-cause mortality. The first secondary outcome was serious adverse events excluding mortality. Risk of bias was assessed, and GRADE was used to evaluate quality of evidence., Results: One hundred and twelve randomised trials were included of which one trial (1%) had low risk of bias. Included trials varied in patients: types of surgery which was expected due to inclusion criteria; in intervention and comparison: timing of intervention, monitoring devices, haemodynamic variables, target values, use of fluids, vasopressors and/or inotropes as well as combinations of these within protocols; and in outcome: mortality was reported in 87 trials (78%). Due to substantial clinical heterogeneity also within the various types of surgery a meta-analysis of data, including subgroup analyses, as defined in our protocol was considered inappropriate., Conclusion: Clinical heterogeneity in patients, interventions and outcomes in perioperative goal-directed therapy trials is too large to perform meta-analysis on all trials. Future trials and meta-analyses highly depend on universally agreed definitions on aspects beyond type of surgery of the complex intervention and its evaluation., (© 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Rationale: Meta-analysed intervention effect estimates are perceived to represent the highest level of evidence. However, such effects and the randomized clinical trials which are included in them need critical appraisal before the effects can be trusted., Objective: Critical appraisal of a predefined set of all meta-analyses on interventions in intensive care medicine to assess their quality and assessed the risks of bias in those meta-analyses having the best quality., Methods: We conducted a systematic search to select all meta-analyses of randomized clinical trials on interventions used in intensive care medicine. Selected meta-analyses were critically appraised for basic scientific criteria, (1) presence of an available protocol, (2) report of a full search strategy, and (3) use of any bias risk assessment of included trials. All meta-analyses which qualified these criteria were scrutinized by full "Risk of Bias in Systematic Reviews" ROBIS evaluation of 4 domains of risks of bias, and a "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" PRISMA evaluation., Results: We identified 467 meta-analyses. A total of 56 meta-analyses complied with these basic scientific criteria. We scrutinized the risks of bias in the 56 meta-analyses by full ROBIS evaluation and a PRISMA evaluation. Only 4 meta-analyses scored low risk of bias in all the 4 ROBIS domains and 41 meta-analyses reported all 27 items of the PRISMA checklist., Conclusion: In contrast with what might be perceived as the highest level of evidence only 0.9% of all meta-analyses were judged to have overall low risk of bias., (© 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)